Class – B are minimally invasive medical devices, you can also call them low-risk devices for example – Heat therapy gel, Foot bath and Cold-air therapy unit. The State Licensing Authority gave permission for the Class B medical devices approvals.
List Of Class B Medical Devices
Go through the list of Class B Medical Devices In India. So you can apply for the regulation of specific devices in India.
Category – Anesthesiology
A list of Class B Medical Devices under the category of Anesthesiology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Aerosol face mask | A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient’s airway. | B |
| 2 | Aerosol inhalation monitor | It is a device that enables a medical professional to objectively assess in detail how the test subject uses their inhaler | B |
| 3 | Airway temperature monitoring system | An assembly of devices is used to continuously measure the temperature at a specific point along a ventilation airway. | B |
| 4 | Anaesthesia breathing circuit | An assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anesthesia unit/workstation to the patient. | B |
| 5 | Anesthesia depth monitor | It is a device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anesthesia), showing the degree of consciousness | B |
| 6 | Anesthesia information system | A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in the analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of anesthesia services. | B |
| 7 | Anaesthesia workstation gas scavenger | A device intended to connect the expiratory valve/port of a breathing circuit and the extraction system enabling the waste anesthetic, exhaled, or other trace gases to be removed under controlled conditions from the work environment and channelled to the outside of the building. | B |
| 8 | Anesthetic gas absorption/desorption device | Artificial airway washing/disinfection jar | B |
| 9 | Artificial airway washing/disinfectionn jar | A container intended to hold artificial airway devices to facilitate their washing/disinfection. | B |
| 10 | Brachial plexus anesthesia kit | A collection of devices intended to deliver a brachial plexus nerve block through one of several routes that could include supraclavicular, inter scalene, infraclavicular, or axillary | B |
| 11 | 2 Breathing circuit gas sampling/monitoring set | A collection of devices intended to be integrated within a breathing circuit to enable the interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient’s expired gas for measurements of pressure, flow, and/or gas analysis. | B |
| 12 | Breathing circuit washer/disinfector | A device intended to, when integrated within the common line of a breathing circuit, absorb and desorb (i.e., recycle) exhaled volatile anaesthetic agents. | B |
| 13 | Bronchoscopy tube | A device that is inserted orally into the trachea to maintain airway patency and/or to deliver anesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope | B |
| 14 | CPAP/BPAP nasal mask | A device designed to be placed over a user’s nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV) | B |
| 15 | CPAP/BPAP oral mask | A device designed to be fitted to the user’s mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). | B |
| 16 | Electronic oesophageal stethoscope | An electronic listening device designed to be inserted into a patient’s esophagus to listen to heart and breathing sounds, typically while the patient is under anesthesia | B |
| 17 | Endobronchial tube | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. | B |
| 18 | Endotracheal secretion monitoring system | An assembly of devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to assess the effectiveness of suctioning | B |
| 19 | Helium/oxygen breathing gas mixer | An independent mechanical device designed for accurate mixing of helium (He) and oxygen (O2) with concentrations that are appropriated for breathing in a patient who is indicated to assist flow of O2 into the alveoli and to reduce the work of breathing | B |
| 20 | Inhalational analgesia unit | A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. | B |
| 21 | Intracardiac oximeter | A photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation | B |
| 22 | Intravascular blood gas/pH monitoring system | An assembly of devices used for the continuous in vivo measurement and display of the values of pH and/or the partial pressure of CO2 and/or O2 in arterial blood. The system is used for patients with respiratory failure or severe pulmonary hypertension after cardiac surgery | B |
| 23 | Intravascular oximeter | An instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2) using a fibreoptic catheter | B |
| 24 | Invasive arterial pressure cardiac output/oximetry monitor | A device intended to continuously measure and display arterial pressure cardiac output (APCO) and haemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter | B |
| 25 | Laryngectomy tube | A device intended to maintain tracheostomy patency after laryngectomy to provide an airway for the patient and to prevent tracheostomy stenosis in the months following the procedure. | B |
| 26 | Laryngotracheal anaesthesia applicator | A non-sterile container that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention of an endotracheal (ET) tube or other type of tracheal tube | B |
| 27 | Medicine chamber spacer | A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient’s mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. | B |
| 28 | Microbial medical gas filter | A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy. | B |
| 29 | Nitric oxide delivery unit | A device intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of the neonate, pediatric, and adult patients to treat severe respiratory disorders | B |
| 30 | Non-heated respiratory humidifier | A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapor to the dry gas as it is passed through, or more seldom, over water. | B |
| 31 | Oxygen/air-breatheng gas mixer | A portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergencies | B |
| 32 | Peak flow meter | A device designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease in a clinical setting or the home. | B |
| 33 | Pleural manometer | A noninvasive device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity. | B |
| 34 | Pneumatic chest percussor | A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease | B |
| 35 | Pressure algometer/aesthesiometer | An instrument designed to measure a patient’s sensitivity to pain (pain threshold) and tactile sensibility | B |
| 36 | Pulmonary function analysis system | A device used to measure the function of the respiratory system in adults and compliant children. | B |
| 37 | Pulse Co-oximeter | A device designed to detect hypoxia via the transcutaneous multiwave measurement and display of carboxyhaemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb). | B |
| 38 | Respiration monitor | A device designed to measure and display a nonambulatory patient’s respiratory functions. Measurements include concentration of respiratory gas components and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). | B |
| 39 | Respiratory oxygen monitor | An instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting. | B |
| 40 | Respiratory oxygen therapy monitor/regulator | An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements | B |
| 41 | Retrograde endotracheal intubation kit | A collection of devices used to assist in the placement of an endotracheal (ET) tube during difficult/emergency airway access procedures | B |
| 42 | Saddle block anaesthesia kit | A collection of devices designed to deliver an analgesic or anaesthetic agent to the lower dural sac in the region corresponding to the buttocks, in the perineum, or to the inner aspects of the thighs. | B |
| 43 | Ultrasonic respiratory humidifier | A device designed to agitate water into micro-particles with ultrasound to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit | B |
| 44 | Vacuum-assisted airway secretionclearing system | A device assembly designed to remove excessive secretion from the lungs and upper airway of patients with respiratory disease or during cardiac rehabilitation through vacuum technology | B |
| 45 | Venturi oxygen face mask | A flexible, cone-shaped device placed over the patient’s nose and mouth to deliver a mixture of an almost precise ratio of air and oxygen to the patient’s airway. The device usually has a replaceable part (Venturi tube) to change the mixture ratio of air and oxygen so that oxygen is delivered at a desired concentration. The device is connected to the oxygen source via a tube. The device has a head strap for fixation. Normally comes with an adapter to connect with a humidifier. | B |
| 46 | Vortex oxygen face mask | A device designed to be placed over the nose and mouth of a patient to deliver a near-precise mixture of air and oxygen (O2) to a patient’s airway without the use of a gas mixer. | B |
Category – Pain Management
A list of Class B Medical Devices under the category of Pain Management is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Acupuncture electrical stimulation system | An assembly of devices used to apply electrical stimuli to acupuncture sites. | B |
| 2 | Acupuncture kit | A collection of instruments and supplies used to perform acupuncture procedures. | B |
| 3 | Acupuncture point detector | An electronic probe is used to precisely locate an acupuncture point on a patient’s body. | B |
| 4 | Analgesic PENS system | An assembly of devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). | B |
| 5 | Analgesic TENS system | An assembly of devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). | B |
| 6 | Arthritis TENS system | An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). | B |
| 7 | Arthritis transcutaneous electrical joint stimulation system | An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating an arthritic joint across the skin (transcutaneously) and providing an overall improvement to an arthritic joint and deferring or avoid surgery. | B |
| 8 | Bed/chair electric massager | A device intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains. | B |
| 9 | Blue/red/infrared phototherapy lamp | A portable device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). | B |
| 10 | Circulating-fluid thermal therapy system | An assembly of devices intended to be used to pump heated and/or cooled fluid through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). | B |
| 11 | Cold-air therapy unit | A unit intended to generate and deliver a stream of cold air directly to the skin surface to treat musculoskeletal/rheumatic disorders, to reduce localized pain/inflammation, and/or to reduce thermal skin damage during dermatological laser treatments. | B |
| 12 | Deep-tissue electromagnetic stimulation system | An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders; 2) treat body pain; and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. | B |
| 13 | Electric pad localized-body heating system | An assembly of devices designed for the transcutaneous application of heat to a localized body site to relieve musculoskeletal pain. | B |
| 14 | Endothermic cold therapy pack | A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. | B |
| 15 | Exothermic heat therapy pack | A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. | B |
| 16 | Foot bath | A device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. This device is intended to relieve foot pain as well as headaches, coughs, and other cold symptoms. | B |
| 17 | Heat therapy gel | A non-sterile gelatinous compound in a container that is dispensed for application to the body surface to provide a warming effect for underlying tissues. It is intended to reduce/relieve pain, and muscle tension, and to increase local circulation. | B |
| 18 | Hydrotherapy bath/tank | A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy | B |
| 19 | Inflatable hot/cold therapy pack/electric pump | A assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury | B |
| 20 | Inhalational analgesia unit | A device primarily designed to administer analgesic gases to the patient or produce analgesic vapours for inhalation. | B |
| 21 | Interferential electrical stimulation system | An device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the treatment point. | B |
| 22 | Intervertebral disc prolapse therapy pack | A device intended to be applied to the skin overlying an affected area of the spine (cervical or lumbar) to reduce pain associated with a prolapsed (herniated) intervertebral disc. | B |
| 23 | Musculoskeletal infrared phototherapy unit | A device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury and to improve blood circulation in the treated areas to facilitate healing. | B |
| 24 | Physical therapy paraffin wax bath | A tub/enclosure, with an internal heating assembly, filled with liquid paraffin wax for physical therapy, to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. | B |
| 25 | Short-wave diathermy treatment system | An assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands. The device is intended to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | B |
| 26 | Static magnetic back/spine insulator | A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin. on the back and/or part or the whole of the spine to help relieve medical ailments agents such as pain, muscle tension, and poor blood circulation and to provide comfort by improving overall mobility. | B |
| 27 | Static magnetic elbow orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the elbow joint to support the elbow and produce a weak magnetic flux field that emanates from the surface of the elbow to assist the whole body’s innate healing capability to alleviate body aches and pains. | B |
| 28 | Static magnetic foot arch orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn in a patient’s shoe, or other footwear, under the arch of the foot to support the arch and produce a weak magnetic flux field that emanates from the surface of the foot arch to assist the whole body’s innate healing capability to alleviate body aches and pains. | B |
| 29 | Static magnetic joint insulator | A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin over/around a patient’s hip or other limb joint to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility | B |
| 30 | Static magnetic knee orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the knee joint to support the knee and produce a weak magnetic flux field that emanates from the surface of the knee to assist the whole body’s innate healing capability to alleviate body aches and pains. | B |
| 31 | Static magnetic lumbar spine orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the hips to support the lower back (spine and coccyx) and produce a weak magnetic flux field that emanates from the surface of the lower back to assist the whole body’s innate healing capability to alleviate body aches and pains. | B |
| 32 | Static magnetic shoulder orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the shoulder joint to support the shoulder and produce a weak magnetic flux field that emanates from the surface of the shoulder to assist the whole body’s innate healing capability to alleviate body aches and pains | B |
| 33 | Static magnetic thoracic spine orthosis | A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the waist or across the shoulders to support the back (central- and upper spine) and produce a weak magnetic flux field that emanates from the surface of the central- and upper spine to assist the whole body’s innate healing capability to alleviate body aches and pains. | B |
| 34 | Wearable cervical spine traction device | An externally worn orthopedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders. | B |
| 35 | Wearable lumbar spine traction device | An externally worn orthopedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. | B |
Category – Cardiovascular
A list of Class B Medical Devices under the category of Cardiovascular is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Cardiac monitor (including cardiotachometer and rate alarm) | A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits. | B |
| 2 | Apex cardiograph (vibrocardiograph) | An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer | B |
| 3 | Enchocardiograph | An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. | B |
| 4 | Electrocardiograph | An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. | B |
| 5 | Vascular Clip | A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels. | B |
| 6 | Vena cava clip | A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava to inhibit the flow of thromboembolic through that vessel. | B |
| 7 | Pacemaker generator function analyzer | A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator’s parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold | B |
| 8 | Cardiovascular permanent or temporary pacemaker electorade | Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. | B |
| 9 | Pacemaker electorate function tester | A pacemaker electrode function tester is a device that is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. | B |
| 10 | Endomyocardial biopsy device | An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart. | B |
| 11 | Cardiopulmonary bypass bubble detector | A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. | B |
| 12 | Cardiopulmonary bypass vascular catheter, cannula, or tubing | A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. | B |
| 13 | Cardiopulmonary bypass heart-lung machine console | A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. | B |
| 14 | Cardiopulmonary bypass heat exchanger | A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device | B |
| 15 | Cardiopulmonary bypass temperature controller | A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger. | B |
| 16 | Cardiopulmonary bypass cardiotomy suction line blood | A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream that will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line. | B |
| 17 | Intraluminal artery stripper | An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arteriosclerotic arteries.) | B |
Category – Dental
A list of Class B Medical Devices under the category of Dental is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Agar dental impression material | An impression material containing reversible agar hydrocolloid as a component for gelation. | B |
| 2 | Alginate dental impression material | An impression material containing alginate as the primary component for gelation. | B |
| 3 | Composite dental impression material | A thermoplastic impression material used to take an impression of the oral cavity. It is a mixture of natural resin, filler, and lubricant. | B |
| 4 | Dental Crown Polymar | A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 5 | Dental crown/bridge resin, temporary | A material used to manufacture crowns and bridges. | B |
| 6 | Dental crown/bridge, temporary | Intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | B |
| 7 | Dental crown, metal/ceramic | A device made of a combination of metal and tooth-colored ceramic, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 8 | Dental crown, metal/polymer | A device made of metal, veneered with a polymer-based, toothcoloured material, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 9 | Dental bone particle collector | A device used to collect bone debris generated by drilling, etc. during oral surgery. | B |
| 10 | Dental suction system | It evacuates solids, liquids, aerosols, and gases from the oral cavity and immediate surrounding area to improve operating effectiveness and efficiency during oral treatment procedures and limit the contamination of the immediate environment. | B |
| 11 | Dental suction system pump | An electrically-powered dental suction pump is used as the suction source of a dental suction system, dental treatment unit, etc. | B |
| 12 | Polyether dental impression material | An elastic material primarily made of polyether, which forms a rubber-like material suitable for taking impressions after reaction. | B |
| 13 | Polysulfide dental impression material | An elastic material primarily made of polysulfide, which forms a rubber-like material suitable for taking impressions after reaction. | B |
| 14 | Silicone dental impression material | An elastic material primarily made of polysiloxane, which forms a rubber-like material suitable for taking impressions after reaction. | B |
| 15 | Dental suction system disinfection control unit | An electrically-powered device intended to control the regular (typically daily) automated/semi-automated disinfection of a dental suction system tubing line. | B |
| 16 | Zinc polycarboxylate dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). | B |
| 17 | A preformed dental crown, permanent | t A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure | B |
| 18 | A preformed dental crown, temporary | This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. | B |
| 19 | Zinc phosphate dental cement | A non-sterile substance intended for professional use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. | B |
| 20 | Dental anesthesia injection kit | A collection of sterile devices designed to inject dental anesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. | B |
| 21 | Dental anaesthesia syringe cartridge | A plastic or glass container prefilled with a single dose of anaesthetic medication intended to be inserted into a dental anaesthesia syringe and injected into oral tissues for a dental procedure | B |
| 22 | Bite registration rim | A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. | B |
| 23 | Bite registration rim wax | A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device. | B |
| 24 | Bite registration rim wax, plate | A dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). | B |
| 25 | Ceramic artificial teeth | Prefabricated teeth made of ceramic (porcelain) for mounting on removable dentures or fixed partial dentures. | B |
Category – ENT
A list of Class B Medical Devices under the category of ENT is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Adenotome blade | Intended to mount on adenectome and perform dissection of adenoids | B |
| 2 | Audiometer | Intended for evaluation of hearing by generating tones throughout the audible range | B |
| 3 | Otoscope | Intended for visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening | B |
| 4 | Auditory evoked-potential graphic recorder | Intended to record an electrical potential that originates in the auditory pathway of the brain in response to acoustic stimuli. | B |
| 5 | Behind-the-ear air-conduction hearing aid | Intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. | B |
| 6 | Behind-the-ear air-conduction tinnitus masker | Intended to provide noise of sufficient intensity and bandwidth to mask tinnitus | B |
| 7 | Ear wick | Intended to minimize bleeding during ear surgery. | B |
| 8 | Electroglottograph | Intended for recording the changes in electrical potential or impedance, resulting from movement of the vocal cords during respiration and phonation. | B |
| 9 | ENT chair, electric | Designed to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. | B |
| 10 | ENT chair, mechanical | Designed to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. | B |
| 11 | ENT shaver system | Intended to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). | B |
| 12 | ENT surgical microscope | Intended to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing | B |
| 13 | Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] in patients | B |
| 14 | Flexible fibreoptic nasopharyngolaryngo scope | Flexible endoscope intended for the visual examination and treatment of the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. | B |
| 15 | Flexible fibreoptic nasopharynx scope | Flexible endoscope intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). | B |
| 16 | Flexible fibreoptic rhinoscope | Flexible endoscope intended for the visual examination and treatment of nasal cavity | B |
| 17 | Flexible fibreoptic sinoscope | Flexible endoscope intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. | B |
| 18 | Flexible video antroscope | Flexible endoscope intended for the visual examination and treatment of a cavity, particularly the pathological changes in the area of the maxillary sinus. | B |
| 19 | Impedance audiometer | Intended to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. | B |
| 20 | ENT Nasal snare | A hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. | B |
| 21 | Otoscope, endoscopic | Intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. | B |
| 22 | Otoscope, direct | Inteded for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. | B |
| 23 | Soft-tissue surgical forceps, alligator | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]. | B |
| 24 | Epistaxis balloon | Device intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery | B |
| 25 | Eustachian tube balloon dilation system | The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. | B |
| 26 | Esophagoscope (flexible or rigid) | Device intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. | B |
| 27 | Mediastinoscope and accessories | A device intended to examine or treat tissue in the area separating the lungs for diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. | B |
| 28 | Laryngostroboscope | A laryngostrobo scope is a device that is intended to allow observation of glottic action during phonation. | B |
| 29 | Powered nasal irrigator | A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity utilizing a pressure-controlled pulsating stream of water | B |
| 30 | Antistammering device | An anti-stammering device intended to minimize a user’s involuntary hesitative or repetitive speech. | B |
| 31 | Wireless air-conduction hearing aid | A wireless air-conduction hearing aid is intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. | B |
| 32 | Hearing aid calibrator and analysis system | A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. | B |
| 33 | Master hearing aid | A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. | B |
| 34 | Battery-powered artificial larynx | A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. | B |
| 35 | Nasal dilator | A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. | B |
Category – Gastroenterology
A list of Class B Medical Devices under the category of Gastroentrology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Absorbent enteric stomal dressing | To be placed over a continent enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained from the intestines) to protect it from harmful external influences, which includes absorbent materials intended to protect the surrounding skin from enteric fluids. | B |
| 2 | Anal fistula circular cutter | To be intended for the circumferential resection of tissue to treat simple anal fistula | B |
| 3 | Anoscope, reusable | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. | B |
| 4 | Anoscope, single-use | A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. | B |
| 5 | Barium enema catheter | A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area | B |
| 6 | Biliary manometric catheter | A sterile, non-electrical flexible tube intended to be inserted into the biliary tree to measure pressures within the ducts, especially to evaluate sphincter of Oddi function. | B |
| 7 | Catheter-balloon inflator, reprocessed | A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.It is typically used during angiography, angioplasty, gastrointestinal (GI), or sinuplasty procedures. | B |
| 8 | Catheter-balloon inflator, reusable | A device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. | B |
| 9 | Catheter-balloon inflator, single-use | A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. | B |
| 10 | Cholangiopancreatograpathy catheter, reusable | A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP) | B |
| 11 | Cholangiopancreatography catheter, single-use | A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, intended for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). | B |
| 12 | Colonic endoscopy cuff | A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. | B |
| 13 | Colonic lavage kit, surgical | A collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction. | B |
| 14 | Colonoscope positioning sleeve | A non-sterile endoscopic sheath with two inflatable balloons designed to be mounted on a colonoscope to position and stabilize the endoscope within the large intestine of a patient. | B |
| 15 | Colonoscope stiffener | A dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. | B |
| 16 | Colorectal sizer | A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. | B |
| 17 | Common bile duct dilator | A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. | B |
| 18 | Endoscope tissue removal cap | A sterile plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue during electrosurgical treatment (e.g., for the treatment of Barrett’s oesophagus). | B |
| 19 | Endoscopic biopsy valve, non-sterile | A non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. | B |
| 20 | Endoscopic biopsy valve, sterile | A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. | B |
| 21 | Endoscopic cutting stapler connector | A rod-like component of an endoscopic cutting stapler intended to enable connection between the stapler handpiece and the endpiece/loading unit | B |
| 22 | Endoscopic electrosurgical biopsy/resection kit, full-thickness | A collection of sterile devices, which includes an implantable haemostatic ligation clip, intended to be used to obtain a full-thickness tissue biopsy and/or therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during an endoscopic procedure | B |
| 23 | Endoscopic electrosurgical biopsy/resection kit, partial-thickness | A collection of devices designed to be inserted through a compatible endoscope to obtain a mucosal tissue biopsy and/or therapeutic resection of upper gastrointestinal (GI) tract tissue, typically during endoscopic retrograde cholangiopancreatography (ERCP) procedures. | B |
| 24 | Endoscopic electrosurgical electrode/submucosal lift needle | A sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation. | B |
| 25 | Endoscopic gastrointestinal stenosis dilator | A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. | B |
| 26 | Endoscopic motorized cutting stapler, reusable | A hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses | B |
| 27 | Endoscopic motorized cutting stapler, single-use | A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses. | B |
| 28 | Endoscopic needleless submucosal lift catheter | A sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. | B |
| 29 | Endoscopic over tube, reusable | A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy) | B |
| 30 | Endoscopic spray catheter | A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal coloration) in spray form. | B |
| 31 | Externally-propelled flexible video colonoscope | A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract] | B |
| 32 | Flexible fibreoptic choledochoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). | B |
| 33 | Flexible fibreoptic colonoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. | B |
| 34 | Flexible fibreoptic duodenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine) | B |
| 35 | Flexible fibreoptic enteroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). | B |
| 36 | Flexible fibreoptic gastroduodenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. | B |
| 37 | Flexible fibreoptic gastroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach | B |
| 38 | Flexible fibreoptic oesophagoscope | An endoscope with a flexible inserted portion intended the visual examination and treatment of the oesophagus | B |
| 39 | Flexible fibreoptic pancreatoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. | B |
| 40 | Flexible fibreoptic sigmoidoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). | B |
| 41 | Flexible ultrasound colonoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. | B |
| 42 | Flexible ultrasound duodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). | B |
| 43 | Flexible ultrasound gastroduodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. | B |
| 44 | Flexible video choledochoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). | B |
| 45 | Flexible video choledochoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. | B |
| 46 | Flexible video colonoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. | B |
| 47 | Flexible video colonoscope, singleuse | A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract] | B |
| 48 | Flexible video duodenoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). | B |
| 49 | Flexible video duodenoscope, singleuse | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine) | B |
| 50 | Flexible video enteroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum) | B |
| 51 | Flexible video gastroduodenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. | B |
| 52 | Flexible video gastroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. | B |
| 53 | Flexible video oesophagoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device. | B |
| 54 | Flexible video oesophagoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. | B |
| 55 | Flexible video pancreatoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. | B |
| 56 | Flexible video sigmoidoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). | B |
| 57 | Gastric tonometry catheter | A sterile flexible tube intended for orogastric, nasogastric, or rectal insertion to sample carbon dioxide (CO2) from the mucosal vasculature of the stomach or sigmoid colon for the measurement of partial pressure (i.e., tonometry) of CO2 (pCO2) during diagnosis of mensenteric ischemia. | B |
| 58 | Gastrointestinal catheter/endoscope tracking system | A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying threedimensional (3-D) virtual images on a monitoring screen. | B |
| 59 | Gastrointestinal endoscopic clip applier | A device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. | B |
| 60 | Gastrointestinal endoscopic clip cutter | A sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip. | B |
| 61 | Gastrointestinal endoscopic clip cutter generator | A portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip. | B |
| 62 | Gastrointestinal manometric catheter, electronic | A non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. | B |
| 63 | Gastrointestinal manometric catheter, non-electronic | A non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. | B |
| 64 | Gastrointestinal/airway foreign body retrieval basket | A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). | B |
| 65 | astro-oesophageal pH/impedance catheter, non-sterile | A non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. | B |
| 66 | Gastro-oesophageal pH/impedance catheter, sterile | A sterile flexible tube with an with an electrical conductor at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastroesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. | B |
| 67 | Gastrostomy tube Y-piece connector | A sterile connecting device shaped in the form of a “Y” intended for connection to the proximal end of a gastrostomy tube to enable the administration of nutrient liquids and/or medication through the gastrostomy tube. | B |
| 68 | Gastro-urological director | A slender, rod-like surgical instrument made of metal, typically with a groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. | B |
| 69 | Gastro-urological probe | A slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. | B |
| 70 | Gastro-urological scoop | A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. | B |
| 71 | Intestinal stoma shield/support belt, reusable | A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. | B |
| 72 | Intestinal stoma shield/support belt, single-use | A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. | B |
| 73 | Intraluminal oesophageal retractor | A sterile, hand-held manual surgical instrument intended to be inserted through an orogastric (or nasogastric) tube to mechanically divert the oesophagus away from the site of surgery during electrical treatments of the heart (e.g., cardiac ablation), to facilitate surgical site access and to help prevent injury to the oesophagus. | B |
| 74 | Invasive silicone sheet dressing | A sterile, flat stretch of silicone elastomer intended for use as a short-term intra-abdominal dressing following abdominal surgery, when a re-exploration of the wound/abdomen is planned within a thirty day period. It is used to achieve temporary abdominal closure to avoid the complications of an open abdomen. | B |
| 75 | Laparoscopic cholangiography catheter/needle | A sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media | B |
| 76 | Laparoscopic grasping forceps, reprocessed | A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. | B |
| 77 | Laparoscopic grasping forceps, reusable | A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. | B |
| 78 | Laparoscopic grasping forceps, single-use | A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure | B |
| 79 | Laparoscopic swab forceps | An instrument designed to grasp a pledget swab at the distal end to obtain cytological specimens and/or to perform blunt dissection during gynaecologic and/or other (e.g., cholecystectomy) laparoscopic procedures. | B |
| 80 | Manual enema device | A non-sterile device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. | B |
| 81 | Manual enema device, reusable | A device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. | B |
| 82 | Manual rectal irrigation system | A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. | B |
| 83 | Motorized laparoscopic forceps | A mains electricity (AC-powered) motorized surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure | B |
| 84 | Nasogastric decompression tube | A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion | B |
| 85 | Nasogastric tube holder, intranasal | A non-sterile, non-surgically invasive device intended to be used to secure a nasogastric tube to the nose of a patient to prevent displacement or removal of the tube. | B |
| 86 | Oesophageal temperature monitor | An electronic device is used to monitor the temperature of the esophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas | B |
| 87 | Over-guidewire oesophageal dilator | A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities | B |
| 88 | Percutaneous biliary biopsy procedure kit | A collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous approach, typically under fluoroscopic visualization | B |
| 89 | Powered rectal/colostomy irrigation system | A portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation | B |
| 90 | Proctoscope, reusable | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus | B |
| 91 | Proctoscope, single-use | A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. | B |
| 92 | Rectal irrigation kit | A collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation | B |
| 93 | Rectal speculum | A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. | B |
| 94 | Rectal suction biopsy system | An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung’s disease (HD)]. | B |
| 95 | Rectoscope, reusable | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus | B |
| 96 | Rectoscope, single-use | A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. | B |
| 97 | Rigid oesophagoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus | B |
| 98 | Rigid sigmoidoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). | B |
| 99 | Robotic surgical retractor | A surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure. | B |
| 100 | Self-propelled flexible video colonoscope | A sterile endoscope with a highly-flexible, self-propelled, inserted portion intended for the visual examination of the entire colon. | B |
| 101 | Spring-loaded pneumoperitoneum needle, reusable | A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. | B |
| 102 | Spring-loaded pneumoperitoneum needle, single-use | A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. | B |
| 103 | Static magnetic anal plug | A non-sterile magnetic device designed to be inserted into the rectum by the user and retained there for a specified period of time (e.g., 1 to 2 hours per day for 10 to 20 days) to help reduce anal hemorrhoids with magnetism. | B |
| 104 | Stoma drainage catheter | A sterile flexible tube that is inserted into a stoma (an artificial opening in the body, especially in the abdominal wall, made during a surgical procedure) to drain bodily waste from an internal stoma container; normally directly into the toilet | B |
| 105 | TEM/TEO rectoscope, optical | An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). | B |
| 106 | TEM/TEO rectoscope, video | An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). | B |
| 107 | Video capsule endoscopy system | An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. | B |
| 108 | Video capsule endoscopy system application software | An individual software application program or group of programs, routines or algorithms that add specific computer-assisted display, processing and analysis capabilities to a video capsule endoscopy system. | B |
| 109 | Video capsule endoscopy system capsule | A non-sterile, battery-powered, electronic component device of a video capsule endoscopy system designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract. B | B |
Category – Urology
A list of Class B Medical Devices under the category of Urology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Biliary/urinary stone retrieval basket, reusable | A flexible manual instrument designed to remove biliary and/or urinary stones (gallbladder and/or renal calculi) from the body during an endoscopic procedure. | B |
| 2 | Bladder-emptying vibratory stimulator | A battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. | B |
| 3 | Cystometer | A device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder. | B |
| 4 | Cystometer probe, ultrasonic | A device that emits ultrasound energy generated by a cystometer in order to study bladder function by measuring bladder capacity, sensation, pressure, and residual urine. | B |
| 5 | Cystoscopic electrode | A sterile electrical conductor intended to be placed in contact with the bladder to stimulate it and/or record its electrical activity for diagnostic examination. | B |
| 6 | Electrohydraulic lithotripsy system | An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. | B |
| 7 | Electrohydraulic/pneuma tic lithotripsy system probe, urinary, single-use | A sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing highspeed fragmentation of the calculus in situ. | B |
| 8 | Electromechanical lithotripsy system, intracorporeal | An assembly of devices designed to create shock waves through electromechanical action for the intracorporeal fragmentation of calculi (stones) in the urinary tract (i.e., kidney, ureter and bladder); the resulting debris may be actively removed or passed out by natural means at a later date | B |
| 9 | Fibreoptic ureteral catheter, reusable | A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end. | B |
| 10 | Filiform urethral bougie | An extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately-threaded urethral catheter. | B |
| 11 | Flexible endoscopic stoneretrieval forceps, reusable | A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. | B |
| 12 | Flexible fibreoptic cystonephroscope | An endoscope with a flexible inserted portion is intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. | B |
| 13 | Flexible fibreoptic cystoscope | An endoscope with a flexible inserted portion is intended for the visual examination and treatment of the bladder and the urinary tract. | B |
| 14 | Flexible fibreoptic cystourethroscopy | An endoscope with a flexible inserted portion is intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. | B |
| 15 | Flexible fibreoptic nephroscope | An endoscope with a flexible inserted portion is intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. | B |
| 16 | Flexible fibreoptic ureterorenoscope | An endoscope with a flexible inserted portion is intended for the visual examination and treatment of the ureter and the renal pelvis. | B |
| 17 | Flexible fibreoptic ureteroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). | B |
| 18 | Flexible fibreoptic urethroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). | B |
| 19 | Flexible ureteral sheath/fibreoptic telescope | A sterile device assembly intended to function as a flexible endoscope for the visual examination and treatment of body cavities/organs that can be accessed via the ureter for cystoscopic, nephroscopic, laparoscopic, and ureteroscopic procedures. | B |
| 20 | Flexible video cystonephroscope | An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys | B |
| 21 | Flexible video cystoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. | B |
| 22 | Flexible video cystourethroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region | B |
| 23 | Flexible video nephroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the kidney. | B |
| 24 | Flexible video ureterorenoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. | B |
| 25 | Flexible video ureteroscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). | B |
| 26 | Flexible video urethroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). | B |
| 27 | General-purpose ureteral catheter | A flexible tube designed for introduction into the ureters through a cystoscope or nephroscope. | B |
| 28 | Hand pneumatic lithotripsy system, urinary | An assembly of devices, held by the operator, that uses pneumatically-created ballistic shock waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidneys, ureters, and bladder) for their removal. | B |
| 29 | Hepatic function analysis system | An assembly of mains electricity (AC-powered) devices intended to aid in the quantitative assessment of liver function by the in vivo measurement of the plasma concentration and clearance of a tracer substance [e.g., indocyanine green (ICG)] in the peripheral vasculature following intravenous injection | B |
| 30 | Incontinence sensor/alarm | A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). | B |
| 31 | Intermittent urethral catheterization kit, nonsterile | A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization | B |
| 32 | Intermittent urethral catheterization kit, sterile | A collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. | B |
| 33 | Intermittent urethral drainage catheter, antimicrobial | A sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding | B |
| 34 | Intermittent urethral drainage catheter, nonsterile | A non-sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., selfapplied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding | B |
| 35 | Intermittent urethral drainage catheter, sterile | A sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. | B |
| 36 | Intracorporeal lithotripsy suction system | An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluidcontaining fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. | B |
| 37 | Intraurethral valve/pump | A sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. | B |
| 38 | Lithotrite | A hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder | |
| 39 | Male urinary outflow analysis system | A mains electricity (AC-powered) assembly of devices intended to be used to measure urine flow rate and to estimate isovolumetric bladder pressure in men with the use of an inflatable penile cuff. It typically consists of a dedicated computer and application software, an automatic cuff inflation/deflation unit, a single-use penile cuff, and a load-measuring cell/stand. | B |
| 40 | Male urinary outflow analysis system cuff | A non-sterile inflatable cuff that is a component of a male urinary outflow analysis system | B |
| 41 | Manometric catheter sheath | A non-sterile, synthetic polymer sleeve intended to cover/protect and prevent contamination of a manometric catheter (including a barostat catheter). | B |
| 42 | Penile extracorporeal shock wave therapy system | A mobile assembly of devices designed to provide spark-gapgenerated, low-intensity, extracorporeal shock wave therapy to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse. | B |
| 43 | Penile extracorporeal shock wave therapy system applicator | A hand-held device designed to transmit spark-gap-generated (electrohydraulic), low-intensity, shock waves from a penile extracorporeal shock wave therapy system generator to the skin of the penile shaft and the penile crura to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse. | B |
| 44 | Penis wearable urinal | A non-sterile, externally-worn, urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag | B |
| 45 | Penis/scrotum wearable urinal | A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. | B |
| 46 | Pyeloscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the renal pelvis and major or minor calyces. | B |
| 47 | Rigid cystoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract | B |
| 48 | Rigid cystourethroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. | B |
| 49 | Rigid nephroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. | B |
| 50 | Rigid ureterorenoscope | An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. | B |
| 51 | Rigid ureteroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder) | B |
| 52 | Rigid urethroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). | B |
| 53 | Rigid video ureterorenoscope | A sterile endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. | B |
| 54 | Spark-gap lithotripsy system | An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a spark-gap generator. | B |
| 55 | Suprapubic needle, surgical, reusable | A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse. | B |
| 56 | Temperature-monitoring indwelling urethral drainage catheter | A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. | B |
| 57 | Transobturator needle, reusable | A hand-held manual surgical instrument with a sharp pyramidal or conical point used to create a percutaneous puncture using the transobturator approach (i.e., the insertion points overlie the obturator space in the genitofemoral crease lateral to the vagina), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. | B |
| 58 | Transvaginal needle, surgical | A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. | B |
| 59 | Ultrasonic lithotripsy system | An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. | B |
| 60 | Ureteral patency kit | A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. | B |
| 61 | Urethral drainage catheter punch | A hand-held manual instrument designed for cutting a small hole (e.g., 0.3 mm diameter) into the distal end of a closed Foley catheter (usually 14.0 French or larger) to form a “Council tip Foley catheter”, allowing it to be placed over a guidewire or ureteral catheter. | B |
| 62 | Urodynamic measurement system | An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters | B |
Category – General Hospital
A list of Class B Medical Devices under the category of General Hospital is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Liquid crystal forehead temperature strip | A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. | B |
| 2 | Electricity powered spinal fluid pressure monitor | Inteded to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. | B |
| 3 | Spinal fluid manometer | A spinal fluid manometer is a device used to measure spinal fluid pressure using nnedle and graduated column | B |
| 4 | Sterilization process indicator (bilogical) | A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization on medical device. | B |
| 5 | Sterilization process indicator (Physical/chemical) | A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on the medical device. | B |
| 6 | Clinical electronic thermometer | A clinical electronic thermometer is a device used to measure the body temperature of a patient | B |
| 7 | Clinical mercury thermometer | A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury. | B |
| 8 | Pediatric medical crib | Intended for medical purposes for use with a pediatric patient. | B |
| 9 | Medical bassinet. | Intended for medical purposes in hospital for use (birth to approximately 5 months of age) in a nursery, labor and delivery unit, or patient room. | B |
| 10 | Pressure infusor for an I.V. bag. | Device inteded to inflate and increases the pressure on the I.V. bag to assist the infusion of the fluid | B |
| 11 | Patient care reverse isolation chamber. | Device inteded protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. | B |
| 12 | Patient lift, Electrcially powered | Inteded to lift and transport patients in hsoptial in the horizontal or other required position from one place to another, as from a bed to a bath. | B |
| 13 | Neonatal phototherapy unit. | A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). | B |
| 14 | Ultrasonic cleaner for medical instruments. | Intended for cleaning medical instruments by the emission of high-frequency soundwaves | B |
| 15 | Sharps needle destruction device | Intended to destroy needles or sharps used for medical purposes by incineration or mechanical means. | B |
| 16 | Remote Medication Management System. | The system is intended to store the patient’s prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient’s prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient’s command, and to record a history of the event for the health care professional. | B |
| 17 | Surgical Light, Single or Multi dome | Intended for medical purposes that is used to illuminate body surfaces and cavities during Surgery. | B |
| 18 | Medical examination light, AC powered or Battery | Intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination | B |
| 19 | Medical ultraviolet air purifier. | A medical ultraviolet air purifier is a device intended for medical purposes in hospital/clinic to destroy bacteria in the air by exposure to ultraviolet radiation | B |
| 20 | Vacuum-powered body fluid suction apparatus. | A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. | B |
| 21 | Washers for body waste receptacles. | A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan | B |
| 22 | Sterilization wrap. | It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used | B |
| 23 | General purpose disinfectants. | A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. | B |
| 24 | Medical washer | Intended for general medical purposes to clean and dry medical devices, which later undergo sterilization or disinfection before use on patient. | B |
| 25 | Blood Vacutainer | Intended for the drawing of a predetermined volume of blood using vaccum to a container containing Ethylenediaminetetraacetic acid. | B |
Category – Operation Theatre
A list of Class B Medical Devices under the category of Operation Theater is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Hemostatic clip applier | A surgical device designed to apply a hemostatic clip for ligation of a blood vessel. | B |
| 2 | Hemostatic knife | The blade intended to transmits heat directly to body tissues to achieve hemostasis. | B |
| 3 | Scalpel | An instrument used to sever and separate body tissues during surgery | B |
| 4 | Scalpel blade | A blade intended to be attached to the handle of scalpe | B |
| 5 | Surgical forceps | A surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues | B |
| 6 | Staple remover | A metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stay closed. | B |
| 7 | Surgical punch | A surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc. | B |
| 8 | Surgical file | A manually operated, hand-held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues. | B |
| 9 | Blood vessel surgical stripper | A surgical instrument used for complete or partial vascular resection. | B |
| 10 | Surgical probe | The device is used to explore sinuses, fistulae, and other cavities and wounds. | B |
| 11 | Powered generalpurpose operation table | A completely mobile surgical table (general-purpose) that has been improved to make it useable for almost all parts of the body that require surgery. Electrically line or battery operated. | B |
| 12 | Operation table system | A system that consists of several components that form a complete surgical table system. It is used to replace tabletops, change the patient’s position, and transfer the patient to and from the operating room. Usually, it consists of columns, a removable tabletop, remote controller for the trolley, and a trolley. | B |
Category – Respiratory
A list of Class B Medical Devices under the category of Respiratory is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Activated-oxygen generator | It is a device that makes activated oxygen (singlet oxygen) wh | B |
| 2 | Aerosol inhalation monitor | It is a device that enables a medical professional to objectively assess in detail how the test subject uses their inhaler | B |
| 3 | Argon gas analyser | An instrument intended to measure the concentration (partial pressure) of argon (Ar) in a gas mixture sample to aid in determining a patient’s ventilatory status. | B |
| 4 | Artificial airway tube cuff pressure monitor | A device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage | B |
| 5 | Bronchoscope | An endoscope with an inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs and take biopsies and sample of secretions | B |
| 6 | Cerebral oximeter | A device used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a patient. | B |
| 7 | Chest-oscillation airway secretionclearing system | Devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease | B |
| 8 | Chest-percussion airway secretionclearing system | Devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 9 | Cold-air diagnostic inhalation system | An assembly of devices intended to be used in the assessment of a pateint suffering from asthma. | B |
| 10 | Cricothyrotome | A hand-held manual surgical instrument intended to be used to perform a cricothyrotomy providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures | B |
| 11 | Diagnostic spirometer | A device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function | B |
| 12 | Electroacoustical airway secretionclearing system | An assembly of devices designed to provide externally applied vibrations to the chest wall of a patient via an electroacoustical transducer (the applicator) to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 13 | Electronic oesophageal stethoscope | An electronic listening device designed to be inserted into a patient’s oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. | B |
| 14 | Foetal pulse oximeter | A photoelectric device designed for the monitoring of intrapartum foetal oxygen saturation (FSpO2) in the presence of a non-reassuring foetal heart rate (FHR) pattern during labour. | B |
| 15 | Heated respiratory humidifier | A device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy. | B |
| 17 | Home-use sleep apnoea recording system | A device intended to continuously measure and record patient physiological parameters during sleep in the home, to facilitate the diagnosis of sleep apnoea. | B |
| 18 | Hypopnea sensor/alarm | An assembly of electronic devices intended for continuous recording of a patient’s pulmonary function parameters using impedance pneumography (IP). | B |
| 19 | Infant apnoea monitor | A device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g., audible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants breathing pattern; a condition known as sudden infant death syndrome (SIDS). | B |
| 20 | Intracardiac oximeter | A photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. | B |
| 21 | Intravascular oximeter | An instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2). | B |
| 22 | Invasive arterial pressure cardiac output/oximetry monitor | A device intended to continuously measure and display arterial pressure cardiac output (APCO) and haemoglobin oxygen saturation (e.g., SpO2) | B |
| 23 | Manual chest percussor | A hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 24 | Medical/surgical string | A sterile slender cord or thick thread, medical grade, designed to temporarily lift vessels, hold tracheostomy tubes in place, or assist in stabilizing various organs, medical instrumentation and accessories | B |
| 25 | Monitoring spirometer | A device designed to measure continuously a patient’s tidal volume or minute volume for the evaluation of the patient’s ventilatory status. | B |
| 26 | Nitrogen monoxide analyser | A device intended to measure nitric oxide (NO), in exhaled air to facilitate diagnosis and management of asthma | B |
| 27 | Nitrous oxide analyse | An instrument used to measure the concentration of nitrous oxide (N2O) in a sample of a gas mixture taken from an enclosed environment such as a healthcare facility, a compressed medical air or gas system, and/or devices used for anaesthesia administration or respiratory therapy | B |
| 28 | Oxygen concentrator | A device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2 to patient | B |
| 29 | Pneumatic chest percussor | A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 30 | Public respirator (2 ply, 3 ply face mask) | A filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency. | B |
| 31 | Pulmonary function analysis system | A device used to measure the function of the respiratory system in adults and compliant children | B |
| 32 | Pulse oximetry telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location for viewing | B |
| 33 | Respiration monitor | A device designed to measure and display a non-ambulatory patient’s respiratory functions. | B |
| 34 | Respiratory apnoea monitoring system | An assembly of devices designed to detect the cessation of breathing (apnoea) in patient who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s) | B |
| 35 | Thoracic bioconductance measurement system | An assembly of devices designed to measure and store bioconductance measurements, analyse the stored data and provide information that can aid a clinician in their evaluation of lesions suspicious of lung cancer | B |
| 36 | Thoracic electrical impedance segmentography system | An assembly of devices designed to perform thoracic bio-impedance measurements to continuously record the distribution of air across 4 quadrants of the lungs, commonly of a neonatal/infant patient to detect changes in lung ventilation at a regional level, to assist in the diagnosis of lung conditions. | B |
| 37 | Thoracic suction pump | A device intended to generate negative pressure specifically for aspiration, to remove fluids, secretions and air to allow for the normal expansion/function of the lungs and/or mediastinum. | B |
| 38 | Tongue-adjustment sleep apnoea treatment system | An assembly of devices intended for home management of obstructive sleep apnoea (OSA) by monitoring breathing parameters during sleep to detect the onset of an apnoea event and reducing pharyngeal obstruction by the tongue. | B |
| 39 | Tracheostoma protector | A patient-worn device in the form of a patch, collar, or cloth designed to be fastened around the neck to protect a tracheostoma orifice against harmful external influences. It is not intended to be used as a shower shield. | B |
| 40 | Tracheotome | A surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). | |
| 41 | Transcutaneous blood gas monitoring system | An assembly of devices designed for the continuous and transcutaneous measurement of a patient’s blood gas parameters detected through the jugular vein (SjvO2). | |
| 42 | Ultrasonic respiratory humidifier | A device designed to agitate water into micro-particles with ultrasound to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit. | |
| 43 | Vacuum-assisted airway secretionclearing system | A device assembly designed to remove excessive secretion from the lungs and upper airway of patients with respiratory disease or during cardiac rehabilitation through vacuum technology | |
| 44 | Whole-body plethysmograph | A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. |
Category – Neurological
A list of Class B Medical Devices under the category of Neurological is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Analgesic PENS system | Intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve as relief of chronic neuropathic pain | B |
| 2 | Analgesic TENS system | Intended to treat pain by transcutaneous electrical simulation on peripheral nerves | B |
| 3 | Analytical scalp electrode | Intended to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. | B |
| 4 | Analytical scalp lead | Intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals during encephalography (EEG). | B |
| 5 | Arthritis TENS system | Intended in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). | B |
| 6 | Cranial perforator | Metallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) by attaching to powered drill/handpiece | B |
| 7 | Diagnostic somatosensory tactile stimulation system | Intended to be used to apply tactile stimuli to the body (e.g., pneumatic activation of a membrane to the fingers and lips) typically for evoked response procedures to investigate the function and potential disorders of the brain. | B |
| 8 | Electroencephalogram (EEG) signal spectrum analyzer. | An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal | B |
| 9 | Electroencephalograph electrode/lead tester. | An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin | B |
| 10 | Electroencephalograph test signal generator | An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph | B |
| 11 | Electroencephalographic electrode cap | Analytical scalp electrodes preconfigured within a head-worn device to use with electroencephalography (EEG). | B |
| 12 | Electroencephalographic longterm ambulatory recorder | Intended to continuously record electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. | B |
| 13 | Electroencephalographic simulator | Intended to produces artificial physiological signals or replays digitally recorded patient data to perform rapid testing, simulating that of an electroencephalograph (EEG) recorder or monitor. | B |
| 14 | Electromyograph | Intended in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles. | B |
| 15 | Electronystagmograph | Intended for detecting the electrical potential caused by eye movements | B |
| 16 | Facial nerve locating system | Intended to locate a facial nerve by applying an electrical stimulus | B |
| 17 | Gait-enhancement electrical stimulation system, external | Intended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying external electrical simulation | B |
| 18 | Gustometer | Intended to measure the threshold of a patient’s taste by applying a variable direct current to the tongue. | B |
| 19 | Interferential electrical stimulation system | Intended to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage | B |
| 20 | Leukotome | Intended to cut brain tissue (i.e., cutting white matter, leukotomy) | B |
| 21 | Magnetoencephalography system | Intended to non-invasively detect, measure, and display bio-magnetic signals produced by electrically-active cortical brain tissue, and that provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy | B |
| 22 | Manual surgical saw, flexible | Intended for cutting bone through a sawing action during neurological or orthopaedic surgery | B |
| 23 | Neuromuscular transmission motion sensor | Intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. | B |
| 24 | Neurophysiologic monitoring system | Devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care. | B |
| 25 | Neurosurgical head holder (skull clamp). | A neurosurgical head holder (skull clamp) is a device used to clamp the patient’s skull to hold head and neck in a particular position during surgical procedures | B |
| 26 | Neurosurgical microscope | Designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. | B |
| 27 | Neurosurgical ultrasound navigation system | Intended for intraoperative imaging of the brain for precise navigation during brain surgery (e.g., resection of malignant brain tumours, treatment of vascular malformations). | B |
| 28 | Otoacoustic emission system | Intended to record and analyse the faint sounds hair cells in the inner ear emit in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. | B |
| 29 | Physical therapy ultrasound/neuromuscular stimulation system | Designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments. | B |
| 30 | Transcranial electrical stimulation system, continuouscurrent and pulsed-current | Intended for one or more psychiatric\neurological therapy types [e.g., transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)]. And to induce a state resembling that of chemically-induced anaesthesia for treating one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction | B |
Category – Personal Use
A list of Class B Medical Devices under the category of Personal Use is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Biosanitizer for Medical devices | Intended for surface disinfection of medical devices, non porous hard-surfaces, medical-equipment, units, as well as in-depth cleaning of small surfaces. | B |
| 2 | Nitrile gloves | Nitrile gloves intended to protect the patient and wearer and required to use where resistance to chemicals, including certain disinfectants such as chlorine is required. Also intended for patient and wearer allergic to natural rubber. | B |
| 3 | Latex surgical glove | Natural rubber based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
| 4 | Non-latex surgical glove | Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
| 5 | chemotherapy spill clean-up kit | Designed to safely clean and dispose of Chemotherapy drug spills. | B |
| 6 | Medical/Cadaver Body Bags | Intended for transporting a human corpse without any spread of biohazard/infectious agent. | B |
Category – Obstetrical and Gynecological
A list of Class B Medical Devices under the category of Obstetrical and Gynecological is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Abortion suction system manual aspirator | A non-sterile, manual, syringe-like device to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation. Aslo used for endometrial biopsy. | B |
| 2 | Cervical anaesthesia kit | For providing intercervical nerve block during gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery.This is a single-use device. | B |
| 3 | Cervical anaesthesia needle, reusable or single use | A sharp bevel-edged, hollow tubular metal instrument intended to be used to administe anaesthetic agent to function as an intracervical nerve-block. | B |
| 4 | Colposcope | Special microscope for examination of female genital organs (e.g., vagina, cervix). | B |
| 5 | Endocervical aspirator | A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manuallypowered suction. | B |
| 6 | Endocervical specimen collection kit, no additive | sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation | B |
| 7 | Endometrial biopsy curette | surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. | B |
| 8 | Endometrial biopsy kit | for the collection of a tissue sample taken from the lining of the uterus (endometrium). | B |
| 9 | Endometrial cytology brush | Abrush used to collect mucosal cell for the pathological diagnosis during endoscopic examination | B |
| 10 | Fallopian tube biopsy everting – balloon catheter | A sterile device intended through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination | B |
| 11 | Fallopian tube catheterization kit | A collection of sterile devices for the transuterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency | B |
| 12 | Fallopian tube insufflator | Active invasive device designed to insufflate the Fallopian tubes with a gas [typically carbon dioxide (CO2)] to maintain tubal patency for a procedure. | B |
| 13 | Fixed-diameter cervical dilator, reusable or single use | To dilate the cervical canal with balloon when uterine does not dilate enough due to inertia uteri. | B |
| 14 | Flexible fibreoptic culdoscope | Flexible endoscope for visual examination, diagnosis, and treatment of urinary bladder and urethra. | B |
| 15 | Flexible fibreoptic hysteroscope | For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 16 | Flexible fibreoptic laparoscope | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs | B |
| 17 | Flexible fibreoptic mammary ductoscope | For the visual examination and treatment of the mammary duc | B |
| 18 | Flexible fibreoptic salpingoscope | For the visual examination and treatment of the fallopian tubes (oviducts). | B |
| 19 | Flexible ultrasound laparoscope | For the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. | B |
| 20 | Flexible video culdoscope | for the visual examination and treatment of the female peritoneal cavity and organs. | B |
| 21 | Flexible video hysteroscope | For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus) | B |
| 22 | Flexible video laparoscope | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. | B |
| 23 | Flexible video mammary ductoscope | For the visual examination and treatment of the mammary duct. | B |
| 24 | Flexible video salpingoscope | For the visual examination and treatment of the fallopian tubes (oviducts). | B |
| 25 | Foetal acoustic stimulator | Uses sound stimuli to assess foetal well-being.This device is used to evaluate the status of the foetus as expressed by, e.g., foetal heart rate changes or foetal acid-base status, in antepartum tests and/or during intrapartum monitoring. | B |
| 26 | Foetal blood sampler | Invasive device to collect fetal blood through uterine cervix | B |
| 27 | Foetal vacuum extraction cup, reusable or single use | A device used to extract the head of the fetus with a vaccum cup. | B |
| 28 | Foetal vacuum extraction system monitor | A battery-powered vacuum measuring device that is connected via tubing to the suction line of a foetal vacuum extracting cup, to measure and record data related to a vacuum-assisted delivery such as level of vacuum applied, the number and duration of pulls, and number of pop-offs. | B |
| 29 | Foetal vacuum extraction system, manual, reusable or single use | To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. | B |
| 30 | Foetal vacuum extraction system, pneumatic | To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. | B |
| 31 | Foetal/maternal multiple physiological parameter simulation kit | To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers | B |
| 32 | Foetal/maternal multiple physiological parameter simulator | To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. | B |
| 33 | Gynaecological scissors, reusable or single use | To cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. | B |
| 34 | Gynaecological surgical microscope | To improve visualization of anatomical structures via transmitted light during gynaecological surgery (e.g., on the fallopian tubes). | B |
| 35 | Hysteroscopic insufflator | A device that sends the gas into the fallopian tube to maintain the patency of the tubes. | B |
| 36 | Hysteroscopic irrigation/insufflation system | used during endoscopic procedures of the uterus to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization and enlarge the surgical field. It also circulates the fluid to provide irrigation that will remove tissue/debris from the site. | B |
| 37 | Intrauterine cannula, reusable or single use | To aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy | B |
| 38 | Intrauterine haemostatic balloon catheter | A sterile, flexible tube with an inflatable balloon inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. | B |
| 39 | Intrauterine haemostatic suction catheter | Inserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions. | B |
| 40 | Intrauterine imaging medium catheter | Intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus. | B |
| 41 | Intrauterine imaging medium catheterization kit | Sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus. | B |
| 42 | Laparoscope laser coupler or laser/laparoscope adaptor | To connect the laparoscope to the laser or the laser arm for laparoscopic laser treatment. | B |
| 43 | Laparoscope system, reprocessed | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). | B |
| 44 | Laparoscope system, reusable or single use | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). | B |
| 45 | Manual expandable cervical dilator | To dilate the cervical canal with balloon when uterine does not dilate enough due to inertia uteri | B |
| 46 | Mechanical foetal heart simulator | To imitate a foetal heart (e.g., foetal heart ultrasound signals) when used in combination with a foetal/maternal multiple physiological parameter simulator in order to test foetal monitoring and recording equipment [e.g., cardiotocograph (CTG)], check patient cable continuity, or to train healthcare providers. | B |
| 47 | Menstrual cup, Hevea-latex | Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. | B |
| 48 | Menstrual cup, non-latex, reusable or single use | Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. | B |
| 49 | Menstrual tampon, scented or unscented | Inserted into the vagina to absorb menstrual or other vaginal discharge. | B |
| 50 | Motorized laparoscopic forceps | Active surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure. | B |
| 51 | Papanicolaou smear kit or Endometrial sampling kit | used to collect and prepare pap smears samples in a medical institute. | B |
| 52 | Pelvic examination kit | For performing pelvic examination | B |
| 53 | Pelvimeter | A measuring device used to determine the pelvic dimensions. | B |
| 54 | Pelviscope | An endoscope used for visual examination and diagnosis of pelvis | B |
| 55 | Perineal warmer | It is useful for pain relief in the vulva after episiotomy | B |
| 56 | Perineometer | To determine perineal muscle strength through resistance to spontaneous contraction of perineal muscle. Also used to diagnose and treat urinary incontinence and sexual dysfunction through movement | B |
| 57 | Pudendal anaesthesia kit | A collection of sterile devices designed to deliver anaesthetic agent to the external genitalia of humans. | B |
| 58 | Resectoscope | An endoscope used for visual examination, diagnosis and treatment, especially for resection, of tissues. | B |
| 59 | Rigid culdscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs. | B |
| 60 | Regid fibreoptic hysteroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 61 | Rigid mammary ductoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mammary duct | B |
| 62 | Rigid optical laparoscope | An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. | B |
| 63 | Rigid salpingoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the fallopian tubes (oviducts) | B |
| 64 | Rigid ultrasound laparoscope | An endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs | B |
| 65 | Rigid video hysteroscope | Acitve device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 66 | Rigid video laparoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs | B |
| 67 | Suprapubic needle, surgical, reusable or single use | Percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair. | B |
| 68 | Uterine injector | Used to inject liquid, drug, or other substance into uterus. It is a reusable device | B |
| 69 | Uterine manipulator cervical cup/transilluminator | Allow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy). | B |
| 70 | Uterine manipulator, reusable or single use | Surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention | B |
| 71 | Uterine packer | A hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device. | B |
| 72 | Uterine probe | For exploring the uterus during a surgical procedure. Used as a component of a uterine manipulator | B |
| 73 | Uterus-supporting pessary | Inserted into the vagina to hold the uterus in place | B |
| 74 | Vaginal dilator | Inserted into the vagina to dilate a narrow vaginal opening due to congenital defect. Can be used during examination, treatment or surgirical procedure | B |
| 75 | Vaginal douche, reusable or single use | To deliver a liquid (usually solution) directly into the vaginal cavity for hygenic purpose as a douche | B |
| 76 | Vaginal douching fluid tablet | A tablet containing various compounds (e.g., sodium bicarbonate, citric acid, aloe barbadensis powder) designed to be dissolved in a vaginal douche. | B |
| 77 | Vaginoscope | For pediatric vaginal examination. To search foreign mattter or bleeding site. | B |
| 78 | Viscera retention paddle or Visceral retainer | Used to hold an organ at proper position (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is also implanted into a surgical site temporarily | B |
| 79 | Amniotome, reusable | A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus | B |
| 80 | Bladder-supporting pessary | inserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse | B |
| 81 | Catheter-tip transducer, pressure | A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. | B |
| 82 | Foetal Doppler system | Active non invasive device to detect foetal heart beats using ultrasound/Doppler technology. | B |
| 83 | Foetal Doppler system probe | placed on the surface of a pregnant woman’s abdomen to detect foetal heart beats using ultrasonic/Doppler technology | B |
| 84 | Menstrual pad, scented | held in place externally to absorb menstrual or other vaginal discharge | B |
Category – Ophthalmic
A list of Class B Medical Devices under the category of Ophthalmic is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Adaptometer | An ophthalmic device intended to measure the time required for retinal adaptation and the minimum light threshold. | B |
| 2 | Contact Lens | Device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. | B |
| 3 | Corneal burr manual instrument | A hand-held, ophthalmic surgical instrument, used to excavate corneal tissue through manual rotation. | B |
| 4 | Corneal burr system | An assembly of devices designed for abrasion of the cornea and other eye tissues. | B |
| 5 | Corneal burr, abrasion | A device designed for abrasion of the cornea to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. | B |
| 6 | Corneal burr, rust ring remova | A device designed for gentle removal of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. | B |
| 7 | Corneal epithelium perforator | Intended to create a number of small perforations in the epithelial layer of the cornea through which riboflavin can pass into the cornea during corneal collagen crosslinking, to treat corneal ectasia (typically keratoconus). | B |
| 8 | Corneal epithelium trephine | Intended to create a circular cut through the epithelial layer of the cornea to create an epithelial flap intended to be folded back during laser assisted epithelial keratomileusis (LASEK) surgery, after which the flap is replaced. | B |
| 9 | Corneal light shield | A device, typically made of a non-abrasive fluid-absorbing material that is placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure. | B |
| 10 | Corneal marker | A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. | B |
| 11 | Corneal resection holder | A device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. | B |
| 12 | Corneal scissors | A hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue. | B |
| 13 | Corneal shield | A mechanical eye shield made of collagen that is placed on the eye toprotect the cornea. | B |
| 14 | Corneoscleral punch | A hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue from the sclera or cornea of a patient or from grafts taken from cadaver donors | B |
| 15 | Epiretinal/inner limiting membrane scraper | A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses | B |
| 16 | Euthyscope | A modified ophthalmoscope that projects a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia. | B |
| 17 | Eye cup | A receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye | B |
| 18 | Eye heat therapy pack | A device intended to be placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis and other related ocular conditions. | B |
| 19 | Eye muscle clamp | An hand-held manual ophthalmic surgical instrument designed to atraumatically grasp and hold the extraocular muscles (EOM) during an ophthalmic surgical intervention. | B |
| 20 | Flieringa ophthalmic ring | A circular band, sutured to the sclera to prevent collapse of the globe during difficult intraocular operations. | B |
| 21 | Keratome | An ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. | B |
| 22 | Lacrimal tube | A implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, and also to facilitate saline solution irrigation to a paranasal sinus to manage chronic rhinosinusitis. | B |
| 23 | Ophthalmic operating table top | A component of a modular operating table intended to provide support for and stabilization of the head of the patient (typically includes a headrest) and to help provide optimal access for the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon). | B |
| 24 | Ophthalmic soft-tissue surgical forceps | A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). | B |
| 25 | Ophthalmic tonometer | An ophthalmic, measuring instrument designed for determining the intraocular pressure (IOP). | B |
| 26 | Ophthalmic ultrasound imaging system | An assembly of devices designed for ophthalmic ultrasound imaging procedures | B |
| 27 | Scleral marker | A manual instrument used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. | B |
| 28 | Ultrasound pachymeter | An ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. | B |
Category – Rehabilitation
A list of Class B Medical Devices under the category of Rehabilitation is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Arthritis TENS system | Intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously) | B |
| 2 | Back/leg/chest dynamometer, electronic | Powered device intended to assess neuromuscular function bymeasuring the force or power exerted by the back, chest, and/or legmuscles during flexion. | B |
| 3 | Balance-training tongue electrical stimulation system | Intended to provide biofeedback for training of balance by sensing body movements and subsequently producing signals which are translated into electrical stimuli applied to the tongue, enabling a patient to correlate electrotactile stimulation with their head and body position during exercise sessions | B |
| 4 | Bed/chair electric massager | Intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains. | B |
| 5 | Bladder-emptying vibratory stimulator | Intended to initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. | B |
| 6 | Circulating-fluid thermal therapy system | Intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). | B |
| 7 | Cold-air therapy unit | Intended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold stream of air during dermatological laser treatments | B |
| 8 | Deep-tissue electromagnetic stimulation system | Intended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. | B |
| 9 | Electric massager | Intended for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | B |
| 10 | Electronic goniometer/kinesi ology sensor | Intended to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. | B |
| 11 | Hand dynamometer/pin chmeter, electronic | Electronic device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. | B |
| 12 | Medium-wave diathermy treatment system | Intended to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. | B |
| 13 | Microwave diathermy treatment system | Intended to produce a therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, typically 2,450 megahertz (MHz) [microwave], to promote tissue healing and pain relief | B |
| 14 | Musculoskeletal infrared phototherapy unit | Intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. | B |
| 15 | Physical therapy paraffin wax bath | Intended to be filled with liquid paraffin wax for physical therapy. | B |
| 16 | Physical therapy steam bath | Intended to apply hot steam as a physical therapy to a patient. | B |
| 17 | Telemetric diagnostic spirometer | It is a Battery powered portable device Intended to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)], and to transmit the pulmonary function data via a communication device to a healthcare professional(s) at a remote server | B |
Category – Physical support
A list of Class B Medical Devices under the category of Physical Support is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| Ankle continuous passive motion exerciser | Electrical device intended to continuously move the ankle joint (e.g., flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. | B | |
| 2 | Chestoscillation airway secretion clearing system | Intended to rapidly inflate and deflate against the chest wall of the patient for promoting airway clearance by creating high frequency chest wall oscillation (HFCWO), resulting in the mobilization of bronchial secretions. | B |
| 3 | Flotation therapy bed, adult | Intended to minimize pressure points on a patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect | B |
| 4 | Flotation therapy bed, neonatal | Intended to minimize pressure points on neonatal patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect | B |
| 5 | Hand/wrist continuous passive motion exerciser | A mains electricity (AC-powered) deviceIntenedd to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. | B |
| 6 | Hip/knee continuous passive motion exerciser | A mains electricity (AC-powered) device Intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee, typically following joint surgery/trauma to promote healing; some types may also operate with patient assistance under controlled active motion (CAM). | B |
| 7 | Intermittent traction system | It is an AC powered electronic device. Intended to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. | B |
| 8 | Physical therapy massager | Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices | B |
| 9 | Shoulder continuous passive motion exerciser | It is a mains electricity (AC-powered) device Intended to continuously move the shoulder joint (e.g., flexion, rotation, adduction/abduction) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. | B |
| 10 | Traction table, linepowered | Intended to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. | B |
Category – Interventional Radiology
A list of Class B Medical Devices under the category of Interventional Radiology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Bone sonometer | A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. | B |
| 2 | Radionuclide dose calibrator | A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients | B |
| 3 | Nonfetal ultrasonic monitor | A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion | B |
| 4 | Ultrasonic pulsed doppler imaging system | An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. | B |
| 5 | Ultrasonic pulsed echo imaging system | An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. | B |
| 6 | Diagnostic ultrasonic transducer | A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. | B |
| 7 | Diagnostic x-ray high voltage generator | A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. | B |
| 8 | Pneumoencephalo graphic chair | A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain) | B |
| 9 | Radiographic film cassette | A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film | B |
| 10 | Radiographic film/cassette changer | A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure. | B |
| 11 | Flexible ultrasound colonoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy | B |
| 12 | Flexible ultrasound duodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. | B |
| 13 | Flexible ultrasound gastroduodenosco pe | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy | B |
| 14 | Flexible ultrasound laparoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. | B |
| 15 | Flexible ultrasound bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. | B |
| 16 | Bladder ultrasound imaging transducer | An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance that steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. | B |
| 17 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging) | B |
Category – Dermatology and Plastic surgery
A list of Class B Medical Devices under the category of Dermatology and Plastic Surgery is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Organ bag. | An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss | B |
| 2 | Low energy ultrasound wound cleaner | A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. | B |
| 3 | Surgical drape and drape accessories | A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. | B |
| 4 | Suture retention device | A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient | B |
| 5 | Wound autofluorescence imaging device | A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information | B |
| 6 | Battery-powered trephine system | A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a batterydriven device | B |
| 7 | Colonoscope, General & Plastic Surgery | Colonoscopes are used for the removal of foreign bodies, excision of tumors or colorectal polyps (polypectomy), and control of hemorrhage. Routine colonoscopy is important in diagnosing intestinal cancer | B |
| 8 | Cryosurgical unit and accessories | A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold | B |
| 9 | Dermal dilator | A device to be temporarily implanted subcutaneously to dilate the surrounding skin. Usually, a balloon is implanted subcutaneously where solutions including saline solution are infused | B |
| 10 | Electricallypowered trephine system | A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard soft tissues, or soft tissues | B |
| 11 | Electrosurgical device for over-thecounter aesthetic use | An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for noninvasive aesthetic use | B |
| 12 | Esophagoscope, General & Plastic Surgery | An endoscope used for visual examination, diagnosis, and treatment of the esophagus. The insertion section changes its shape corresponding to the shape of the body cavity. The device is inserted through the oral cavity | B |
| 13 | Gas-powered dermatome | A gas pressure-operated surgical device used to cut a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose. | B |
| 14 | Gas-powered surgical saw | A saw has a handpiece with an attachment that generates vibration or reciprocal movements. It adopts either a micro or macro design. Rechargeable batteries are used. Usually, compressed air or compressed nitrogen is used. | B |
| 15 | Gas-powered trephine system | A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a gasdriven device. | B |
| 16 | Hemostatic knife | A surgical severing instrument that is similar to a scalpel, excluding the fact that its blade is designed to be heated with an electric current. The blade transmits heat directly to body tissues to achieve hemostasis. The instrument uses thermal energy for the purpose and requires no grounding pad. | B |
| 17 | Irrigating wound retractor device. | An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound | B |
| 18 | Liposuction catheter | A rigid tube inserted into the subcutaneous layer transdermally for removal of fatty deposits. Aspiration is performed with an appropriate unit. This device is for single-use. | B |
| 19 | Powered corneal trephine | An electric cylindrical device for ophthalmic surgery equipped with a blade for resection/removal of a ringshaped piece of corneal tissue (corneal button). For example, when a healthy corneal graft is obtained from a cadaver, the recipient’s morbid cornea is resected and removed to allow transplantation of the graft. | B |
| 20 | Powered dermatome | An electric surgical device used for removal of the fragment of damaged skin or for thinly slicing the skin of a donor for skin graft. A dedicated blade should be used for these purposes. | B |
| 21 | Removable skin clip | A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable | B |
| 22 | Removable skin staple | A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable. | B |
| 23 | Single-use dermatome blade | A blade, available in various sizes, attached to a dermatome for collection of skin grafts. The device is intended for single-use. | B |
| 24 | Skin Stapler | Skin Stapler is intended to be applied to close lacerations on the outer layer of the dermis. | B |
| 25 | Soft tissue trephine | A cylindrical or coronary saw used to resect discs of tissues other than bones. It comes in various sizes and configurations according to the size and hardness of the tissue to be resected. | B |
Category – Pediatrics and Neonatology
A list of Class B Medical Devices under the category of Pediatrics and Neonatology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Aerosol tent, paediatric | A flexible enclosure designed to cover the bed of a infant or small child to provide an aerosolized environment of breathing gases/vapours, e.g., a suspension of medicated liquid or solid particles, for medication therapy. Typically used for the treatment of breathing disorders (e.g., asthma). It typically consists of a metal frame covered with transparent plastic, and wide bore tubing connected to the aerosol source and is used for the treatment of paediatric patients permitting them movement without restriction. This is a reusable device. | B |
| 2 | Airway Pressure / Oxygen Monitor | A mains electricity (AC-powered) device designed to continuously measure and display the breathing circuit pressure and oxygen (O2) concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems such as continuous positive airway pressure (CPAP) systems or ventilator respiratory circuits. It typically includes pressure and O2 level displays, alarms to signal pressure and O2 levels that exceed specified limits, and has connectors to allow attachment to the respiratory equipment; it is used for neonatal, paediatrics and adults. It may contain one or more rechargeable battery for independent/mobile use or when mains power is not available. | B |
| 3 | Anaesthesia Facemask, single use (paediatric) | A flexible, form-shaped device designed to be placed over a patient’s nose and/or mouth to direct anaesthetic gases to the upper airway. It is intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. It may be stabilized with a headstrap. It is constructed of nonwoven materials such as conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient’s face. It typically includes a 15 mm connector (paediatric), and is available in a range of sizes. This device is sometimes used in association with a manual resuscitator. It is a single use, disposable device that is provided nonsterile | B |
| 4 | Anaesthesia Facemask, reusable (paediatric) | A flexible, form-shaped device designed to be placed over a patient’s nose and/or mouth to direct anaesthetic gases to the upper airway. It is intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. It may be stabilized with a headstrap. It is constructed of nonwoven materials such as conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient’s face. It typically includes a 15 mm connector (paediatric), and is available in a range of sizes. This device is sometimes used in association with a manual resuscitator. It is reusable | B |
| 5 | Circulating-air whole-body heating/cooling system pad, reusable | An underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device. | B |
| 6 | Circulating-air whole-body heating/cooling system pad, singleuse, sterile | A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device. | B |
| 7 | Circulating-fluid whole-body heating/cooling system pad, reusable | An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device | B |
| 8 | Circulating-fluid whole-body heating/cooling system pad, singleuse | A non-sterile underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partialbody). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device. | B |
| 9 | Closed-ended adhesive infant/paediatric urine collection bag | A sterile, flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/paediatric patient. It is not designed with an opening for urine drainage and is typically used for biochemical, cytological and/or bacteriological sampling. This is a single-use device. | B |
| 10 | Electric pad whole-body heating system | An assembly of mains electricity (AC-powered) devices designed to heat a patient’s whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full- /partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units. | B |
| 11 | Electric pad whole-body heating system pad | An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device | B |
| 12 | External counterpulsation system, paediatric | A noninvasive, stationary assembly of devices intended to assist the blood circulation of a paediatric patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with attached inflatable cuffs, an air pump, ECG cables, a control unit with dedicated software, and may include additional monitoring devices (e.g., pulse oximeter probe). The cuffs are intended to inflate from the most distal (e.g., lower leg) to the most proximal (e.g., buttocks) during diastole and deflate during systole to achieve increased preload and decreased afterload. | B |
| 13 | External defibrillator electrode, paediatric, reusable | An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It usually consists of a cable set that terminates with small-diameter, hand-operated electrodes (paddles) that are held by the operator to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device. | B |
| 14 | External defibrillator electrode, paediatric, single-use | An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with small-diameter, self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device. | B |
| 15 | Hepatic ultrasound elastography system applicator | A non-sterile hand-held device designed to be used for the transcutaneous measurement of liver stiffness based on transient elastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient vibration that produces a mechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements can be used to calculate a measure of liver stiffness/ultrasonic attenuation of tissues. The device is designed to connect to a control unit and may be available in various forms for different applications [e.g., paediatric, bariatric (obese)]. This is a reusable device. | B |
| 16 | Infant bed crib top | A covering made of a metallic, plastic, or metallic/plastic combination structure designed for secure/permanent attachment to the top of an infant bed (i.e., a cradle or crib) to protect the infant from accidental damage. Commonly called a crib top, it is typically a rigid structure with a flexible, transparent plastic (e.g., vinyl) covering around it forming a canopy that encloses the bed. | B |
| 17 | Infant bed restraint | A device designed to limit totally or partially the movement of infants and/or toddlers when lying in its bed or crib; this may be a belt or a strap, or to prevent them from falling out of a bed after climbing the bedrail (e.g., a cover or net). This is a reusable device. | B |
| 18 | Infant heat shield | A protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming of primarily premature infants. This is a single-use device. | B |
| 19 | Infant resuscitation cabinet | A small chamber, usually wall-mounted, used for the emergency resuscitation of newborn infants who do not breathe spontaneously at birth and are oxygen deficient. It typically has a front door or lid that folds out to serve as a surface upon which the infant is placed. It is typically equipped with a heating lamp, a low-pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or empty, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier | B |
| 20 | Infant resuscitation table | A flat surface fixed on legs and on which newborn infants who do not breathe spontaneously at birth and are oxygen deficient are placed for emergency resuscitation. It is typically equipped with a heating lamp and sometimes a supplemental heating pad, a lowpressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or not, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier). This device is typically fixed in one place. | B |
| 21 | Liquid crystal vein locator | A non-sterile device designed to measure skin temperature at several different points using liquid crystal sensors (usually formed from esters of cholesterol which are sealed in a plastic band) placed on the skin around the forearm in order to assist a healthcare professional to locate peripheral veins in a patient before venipuncture. The device is used in paediatric, geriatric, and other patients with hard-to-find veins. This is a single-use device. | B |
| 22 | Neonatal chest percussor | A hand-held battery-powered device (a percussor) intended to be operated by a healthcare professional to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. It is small enough in physical dimension and weight to be operated inside an infant incubator and has a percussion head suitable for the thorax of a neonate. It is used to help loosen secretion build-up in the lungs of neonates who cannot perform the natural cough mechanism. | B |
| 23 | Neonatal electrocardiographic electrode | A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typically an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device | B |
| 24 | Neonatal hypothermia cot | An assembly of non-powered devices intended to induce and sustain mild hypothermia in a neonatal patient to treat hypoxicischemic encephalopathy (HIE). It consists of an insulated cradle, a heat-retention pad(s), and a patient-contact heat-conduction mattress. The heat-retention pad(s) is intended to be cooled in a refrigerator prior to use, and is constructed of a phase change material designed to help maintain patient hypothermia for a prolonged period. This is a reusable device | B |
| 25 | Neonatal hypothermia cot heatconduction mattress | A non-sterile, patient-contact component of a neonatal hypothermia cot assembly intended to be used during induction of mild hypothermia in a neonatal patient by allowing heat transfer away from the recumbent patient. It is typically gel-filled and intended to be placed between the patient and a cooled heat-retention pad. This is a reusable device | B |
| 26 | Neonatal hypothermia cot heatretention pad | A non-sterile, non-powered component of a neonatal hypothermia cot assembly intended to be used to induce and sustain mild hypothermia in a neonatal patient to treat hypoxic-ischemic encephalopathy (HIE). It is intended to be cooled in a refrigerator prior to use, and is constructed of a phase change material designed to retain heat and help maintain patient hypothermia for a prolonged period. This is a reusable device | B |
| 27 | Neonatal pulmonary surfactant catheter | A sterile, flexible, single-lumen tube intended to be introduced into the trachea of a neonate for the administration of exogenous surfactant as part of pulmonary surfactant therapy. It may have a curved distal end to assist navigation into the trachea, and is usually used to treat neonates at a high-risk of infant respiratory distress syndrome [surfactant deficiency disorder (SDD)]. This is a single-use device | B |
| 28 | Non-rechargeable public semiautomated external defibrillator electrode, paediatric | An electrical conductor, with integral batteries and regulated by a dedicated external pulse generator (EPG), designed to create an electrical shock(s) and defibrillate the heart (restore normal rhythm) to treat ventricular fibrillation or pulseless ventricular tachycardia in a pre-pubescent patient. It is a cartridge-type electrode, in pairs, with non-rechargeable batteries that provide the energy to produce the electrical shock(s) after its adhesive pads are placed on the skin of the patient. This is a single-use device that is replaced after a patient application or after elapse of its expiry date. | B |
| 29 | Open-ended adhesive infant/paediatric urine collection bag | A sterile, flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device | B |
| 30 | Ophthalmic tonometer, batteryoperated | An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients. | B |
| 31 | Orthopaedic medialization instrument | A surgical instrument used to restore the anatomical and mechanical axes during orthopaedic correction osteotomies. It is typically designed as a robust block with a long, thin, adjusting rod running through its centre and an incremented measuring scale that enables the surgeon to gauge the adjustments made to the axes (the medialization). It is usually attached to a dedicated bone plate which is bridging the osteotomy site in order to achieve the correct offset of the two separated bone sections. It is typically made of high-grade stainless steel and can be used on adult and paediatric patients. This is a reusable device. | B |
| 32 | Oxygen administration tent, neonatal/paediatric | A flexible enclosure designed to cover the bed of a neonatal or small child to provide an enriched environment of oxygen (O2) to increase the patient’s O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It typically consists of a metal frame covered with transparent plastic, the tubing, and may have built-in humidification. It is used for the treatment of breathing disorders in infant and paediatric patients permitting them movement without restriction. This is a reusable device. | B |
| 33 | Paediatric bed | A bed with appropriate size for children (typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and moveable and latchable siderails. It allows children complete freedom in bed without the danger of falling out, yet allows staff access to the patient. Paediatric beds are not appropriate for neonates/infants. | B |
| 34 | Paediatric blood donor set | A sterile assembly consisting of multiple collection containers (typically five connected flexible bags) of smaller volume than those used in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in order to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later infusion. This is a single-use device. | B |
| 35 | Paediatric dental chair, electric | A mains electricity (AC-powered) device designed to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units. | B |
| 36 | Paediatric dental chair, mechanica | A manually- or hydraulically-powered device designed to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as selfsupported, wall- or ceiling-mounted units. | B |
| 37 | Paediatric strabismus screening scanner | An electrically-powered optic device designed for screening for strabismus and amblyopia risk in children (aged 2 to 8 years) by using retinal reflections of polarized laser light to/from both eyes simultaneously. It consists of a self-contained unit which includes a visually enticing interface for the child to look at, and provides a result, in the form of a recommendation for referral to an ophthalmologist, if an abnormality is detected. | B |
| 38 | Paediatric-temperature nasogastric/orogastric tube | A sterile, thin, flexible, hollow cylinder designed as a paediatric or neonatal enteral feeding tube with an integrated temperature sensor that continuously measures oesophageal temperature. It is typically intended to provide gastric feeding or deliver oral medication via a nasogastric or orogastric route, and to capture the oesophageal temperature for a period (e.g., up to 30 days) via a thermistor sensor located near the distal tip. It is available in various diameters and may connect to a compatible patient monitoring device. This is a single-use device. | B |
| 39 | Blanket/pad infant phototherapy unit | A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanketlike wrap or pad which emits the light and covers or encloses the neonate’s body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use. | B |
| 40 | Flotation therapy bed, neonatal | A fixed (non-adjustable) device designed with a mattress or cushions containing air, water, gel, or other appropriate material used for the continuous care of newborns, and sick and/or premature babies. It has a size to suit such patients and provide environmental conditions (e.g., softness, illumination levels) appropriate for a neonate, as well as good working conditions for the healthcare staff; the bed is frequently mounted on wheels and may include or permit attachments for/to a baby warmer. | B |
| 41 | Otoacoustic emission system, battery-powered | An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device). | B |
| 42 | Otoacoustic emission system, linepowered | An assembly of mains electricity (AC-powered) devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device). | B |
| 43 | Overhead infant phototherapy unit | A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected | B |
| 44 | Thoracic electrical impedance segmentography system | An assembly of devices designed to perform thoracic bio-impedance measurements to continuously record the distribution of air across 4 quadrants of the lungs, commonly of a neonatal/infant patient. It consists of a mobile support/trolley, a mains electricity (ACpowered) central unit with a display, and may include the appropriate patient electrodes. It is intended to detect changes in lung ventilation at a regional level, to assist in the diagnosis of lung conditions (e.g., atelectasis, pneumothorax, misplacement of endotracheal tube, effects of surfactant administration). | B |
| 45 | Thoracic electrical impedance segmentography system electrode array | A non-sterile, noninvasive component of a thoracic electrical impedance segmentography system intended to be attached to the skin surface of a neonatal/infant patient, to transmit electrical signals back to the system, for the continuous recording of the distribution of air across 4 quadrants of the lungs to assess a variety of pulmonary conditions/treatments (e.g., atelectasis, pneumothorax, endotracheal tube misplacement, effects of surfactant administration). It is a dedicated configuration of multiple electrodes. This is a single-use device | B |
| 46 | Wearable neonatal heart rate mete | An electrically-powered device designed to detect and display the heart rate of a neonate, typically within the first few hours after delivery. It consists of a display screen with sensor arms on each side, which are placed around the torso of the newborn. This is a reusable device. | B |
| 47 | Antimicrobial infant garment | A piece of clothing (e.g., baby grow) intended to be worn by an infant affected by an infectious or infection-susceptible skin condition (e.g., eczema, psoriasis, epidermolysis bullosa) to help manage the condition by reducing microbial proliferation through fabric. It is constructed of a material which can prevent/control microbial growth (e.g., silk treated with a silica–ammonium chloride compound). It is available in various sizes for daily use in the home or healthcare facility. This is a reusable device. | B |
| 48 | Boiling water sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical/dental devices and related products using boiling water as the sterilizing agent. It typically consists of a container intended to be filled with water, in which devices are submerged, and an apparatus to boil the water for a specific period. The device is almost exclusively used in remote areas, at home (e.g., for baby bottle sterilization), and/or in emergency situations. | B |
| 49 | Resuscitator face mask, reusable | A flexible, form-shaped device that is placed over a patient’s nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient’s face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a reusable device | B |
| 50 | Resuscitator face mask, single-use | A non-sterile, flexible, form-shaped device that is placed over a patient’s nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient’s face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device | B |
| 51 | Warming infant bed, adjustable | A mains electricity (AC-powered) bed specifically designed for a newborn, sick, or premature baby that requires additional heating provided by a heating pad system. It is typically ergonomically designed for the attending/nursing staff or parents and the motorized mechanism is used to electrically adjust the height and possibly tilt the bed to provide better access to the baby. It may be equipped with features such as shelves, drawers, a canopy, and is typically used in the maternity department. | B |
| 52 | Warming infant bed, non-adjustable | A non-adjustable bed (has a fixed height and mattress platform) specifically designed for a newborn, sick, or premature baby that requires additional heating provided by a heating pad system. It is typically ergonomically designed to provide good access to the baby by the attending/nursing staff or parents. It may be equipped with features such as shelves, drawers, a canopy, and is typically used in the maternity department. | B |
| 53 | Blanket/pad infant phototherapy unit tester | A portable device intended to be used in conjunction with a light meter to test a blanket/pad infant phototherapy unit. The phototherapy unit is typically positioned over specific areas of the test device at set distances to provide a measurement of light, such as average light output. It typically consists of a plastic stencil-like shape designed so the radiometer may fit at a number of positions. It is intended to be used by a healthcare professional in a clinical setting. | B |
| 54 | Blood transfusion set, exchange | A sterile, intravascular administration set used to remove a diseased infant’s blood and replace it with fresh donor blood or plasma. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device. | B |
| 55 | Blue light radiometer | An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants. It typically includes a pre-filter intended to remove wavelengths of light not in the 400-500 nm range (e.g., infrared light); a primary detector consisting of a temperature-stabilized, solid-state [e.g., selenium (Se) or indium-gallium-arsenide] device used to detect radiation; electronic circuits including an amplifier and a electric meter; a power source (e.g., a battery); and a display showing the results either in analogue or digital format. | B |
| 56 | Cranial orthosis | A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded. | B |
| 57 | Multi-purpose saline solution | A sterile, water-based, salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care. It is normally available (non-prescription) over-the-counter (OTC) for home use. After application, this device cannot be reused. | B |
| 58 | Pulmonary function analysis system, paediatric | A computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can’t be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities. | B |
| 59 | Reactive-gel heating pad | An underlay intended to produce heat through chemical reaction typically used to warm and/or maintain the body temperature of neonates or infants. It is typically designed with a soft outer casing (e.g., a soft plastic) that contains a chemically-reactive-gel activated by the user (e.g., by breaking its inner enclosure) to provide a heat of approximately normal body temperature (e.g., 38° Celsius) for a limited period. This device is typically used to maintain the body temperature of infant patients during transportation and may be x-ray translucent and magnetic resonance imaging (MRI) compatible. This is a single-use device. | B |
| 60 | Rocking infant bed, electric | A mains electricity (AC-powered) bed designed to provide a motorized rocking movement for newborn babies to soothe the infant. The motorized mechanism is control-adjustable to provide variable degrees of movement and speed. | B |
| 61 | Teething device, fluid-filled | A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device. | B |
| 62 | Visual-reinforcement-audiometry reward system | An assembly of mains electricity (AC-powered) devices intended to be used in conjunction with an audiometer to reward an infant/child during instrumentation conditioned reflex audiometry/play audiometry. It includes hardware (e.g., monitor, lights) intended to give the child a visual reward, and dedicated operating software; it may include additional controls (e.g., foot-switch) and toys. It is intended to be operated by the healthcare professional to build the conditioned response during auditory testing. | B |
Category – Oncology
A list of Class B Medical Devices under the category of Oncology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Bladder instillation buffer solution | A sterile buffer solution intended to be used exclusively for bladder instillation to help create an optimal environment necessary for the effective treatment of superficial bladder cancer with a chemotherapy agent. | B |
| 2 | Colonic cytology sampling set | A collection of non-sterile devices intended to collect exfoliated colonic cells (colonocytes) from the surface of human rectal mucosa for colorectal cancer investigation and/or patient screening | B |
| 3 | Colposcope | An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia | B |
| 4 | Acupressure wristband | A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. | B |
| 5 | Bladder brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder. | B |
| 6 | Brachytherapy system chair | A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a remote afterloading brachytherapy system applicator. It will typically be height-adjustable and may have a reclining back. | B |
| 7 | Brachytherapy system remote afterloading source transfer tube | A tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. | B |
| 8 | Cervical cytology scraper, singleuse | A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device. | B |
| 9 | Cervical/intrauterine brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, of single or multiple radioactive sources at a treatment site. | B |
| 10 | Class-I biological safety cabinet | A furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials. | B |
| 11 | Elastomeric infusion pump system | It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device. | B |
| 12 | Externally-propelled flexible video colonoscope | A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract].It is used for the screening of colorectal cancer and the detection of other diseases of the lower GI tract. This is a single-use device. | B |
| 13 | Facial prosthesis | An externally-applied device intended to be used as an artificial substitute for parts or sections of the face [e.g., nose, eye(s), eye brows, upper lip] to help restore facial appearance. | B |
| 14 | Flexible fibreoptic bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. | B |
| 15 | Flexible fibreoptic colonoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device. | B |
| 16 | Flexible fibreoptic duodenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures and mucous membranes of the duodenum, for conditions like ulcers, polyps and cancers. This is a reusable device. | B |
| Flexible fibreoptic gastroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device. | B | |
| Flexible fibreoptic sigmoidoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during the procedure called a sigmoidoscopy or a proctosigmoidoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, polyps. This is a reusable device. | B | |
| Flexible video bronchoscope, reusable | An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device | B | |
| Flexible video colonoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device. | B |
Category – Radiotherapy
A list of Class B Medical Devices under the category of Radiotherapy is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Brachytherapy system chair | A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a remote afterloading brachytherapy system applicator. | B |
| 2 | Compact thermoluminescent dosimetry electrometer | Thermoluminescence dosimeter (TLD) is used to measure the radiation dose emitted to the phantom, eyes and other organs with high radiosensitivity. | B |
| 3 | Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy | A device that is specifically designed to be inserted in the vagina to properly position and fix the surrounding organs such as uterine cervix, rectum, and urinary bladder for image diagnosis or radiotherapy. This device is used to facilitate reproducible positioning for continuous image examination or continuous radiotherapy | B |
| 4 | Laser irradiation therapy kit | A kit includes a puncture needle, a guide wire, and a guiding sheath for guiding probes (used for laser irradiation therapy, for example). Not all of the components are included; in some products, two or more of components are integrated into one. | B |
| 5 | Light beam patient position indicator | A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. | B |
| 6 | Manual radionuclide applicator system | A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy | B |
| 7 | Non-powered accelerator system table | A mechanically-operated bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for radiotherapy that uses a medical linear accelerator or nonlinear accelerator. | B |
| 8 | Non-powered neutron therapy table | A bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses neutron rays that are generated from a nuclear reactor, etc. It is equipped with a table top that fixes the posture, pneumatic control, magnetic lock, crank, and lever for mechanical tabletop positioning control and table height control. | B |
| 9 | Radionuclide brachytherapy table | A programmable bed for electric radiotherapy to adjust the patient’s posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically. | B |
| 10 | Non-powered remote irradiation therapy table | A bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus | B |
| 11 | Non-powered X-rays radiation therapy table | A bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses an X-ray therapy apparatus. | B |
| 12 | Operator radiation protection spectacles | A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. | B |
| 13 | Patient positioning device for pelvis diagnostic imaging and radiotherapy | The device that consists of frames, plates, or other parts, and is specifically designed to properly position and fix the patient’s abdomen and pelvic region for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy | B |
| 14 | Patient positioning device for whole body diagnostic imaging and radiotherapy | A device that consists of fixed or adjustable parts (e.g., frames and plates), and is specifically designed to properly position and fix the patient’s whole body for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy. | B |
| 15 | Powered neutron therapy table | A programmable bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses neutron rays that are generated from the nuclear reactor, etc | B |
| 16 | Powered patient table for accelerator | A bed operate by programmable for electric radiotherapy designed to adjust the patient’s posture and immobilize the patient for radiotherapy that uses medical linear accelerator or non-linear accelerator. | B |
| 17 | Powered radionuclide brachytherapy table | A programmable bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically. | B |
| 18 | Powered remote irradiation therapy table | A programmable electrically operated bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses a remote cobalt 60 radiotherapy apparatus and other remote radionuclide radiotherapy apparatuses | B |
| 19 | Powered X-rays radiation therapy table | A programmable electrically operated bed for radiotherapy designed to adjust the patient’s posture and immobilize the patient for treatment that uses an X-ray therapy apparatus. | B |
| 20 | Radiographic Protective Glove | A personnel protective glove is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation | B |
| 21 | Radionuclide dynamic function testing equipment | A device used to measure and record temporal variations of radioisotope concentrations in the body. Specialized devices, such as devices for thyroid uptake measurement, renograms, and radioisotope blood volume measurement, are included. | B |
| 22 | Stationary radiation protection barrier | A device for permanent installation that forms a structural barrier that shields or attenuates radiation emitted from primary radiation source or scattered radiation source | B |
Category – Nephrology and Renal Care
A list of Class B Medical Devices under the category of Nephrology and Renal Care is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Urinary stone retrieval basket | Intended to remove urinary stones ( renal calculi) from the body during an endoscopic procedure. | B |
| 2 | Dialyser connector | Intended to connect between a dialysis fluid circuit and dialyzer, etc | B |
| 3 | Flexible fibreoptic nephroscope | Intended for the visual examination of internal structures and treatment of the kidney (eg: renal calcus) by insering percutaneously into the renal pelvis during nephroscopy. | B |
| 4 | Hemodialysis blood tubing/Extracorporeal systems for blood purification | Sterilized blood tubing intended for hemodialysis (including hemofiltration and hemodiafiltration). | B |
| 5 | Laser lithotripsy fibre/suction guide | Intended to function as a channel for insertion of the laser fibre of a laser beam guide (e.g., of a general/multiple surgical laser system) in nephroscope, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. | B |
| 6 | Peritoneal dialysis catheter guidewire | A guidewire used temporarily for correction of the position of a peritoneal dialysis catheter. | B |
| 7 | Peritoneal dialysis ultraviolet irradiation unit | intended for ultraviolet irradiation of components of peritoneal dialysis transfer tube set. | B |
| 8 | Rigid nephroscope | Intended for visual examination, diagnosis, and treatment of the kidney, renal pelvis, major calyces, and minor calyces by percutaneously inserting scope into the renal pelvis. | B |
| 9 | Shunt thrombus suction set | A set used to suction a thrombus developing inside an arteriovenous shunt (external shunt) during procedures including hemodialysis. | B |
| 10 | Portable continuous peritoneal perfusate thermal conditoner | A device that heats the peritoneal perfusate before injection into the peritoneal cavity. The perfusate is usually heated through direct contact of the dialysis fluid bag with the radiant heat source | B |
| 11 | Citric acid haemodialysis system cleaning cartridge | Intended for the in-line preparation of a citric acid solution to clean/disinfect the fluid pathways of the system (remove calcium and magnesium deposits) in combination with a heat disinfection program | B |
| 12 | Extracorporeal circuit waste bag | Intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. | B |
| 13 | Haemodialysis dialysate water chlorine test kit/strip | Intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. | B |
Category – Software
A list of Class B Medical Devices under the category of Software is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
| 1 | Continuous Glucose Monitor Secondary Display | The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient’s continuous glucose monitoring system sensor glucose information in real time. | B |
| 2 | Insulin Pump Secondary Display | The purpose of the insulin pump secondary display is to notify another person of the patient’s insulin pump usage information in real time. | B |
| 3 | Electrocardiograph Software for home use. | Device intended for home use which creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias | B |
| 4 | Photoplethysmogra ph Analysis Software for home use. | Photoplethysmograph analysis software device for home analyzes of photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a clinical diagnosis | B |
| 5 | Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease | The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests. | B |
| 6 | Ataxiagraph With Interpretive Software | Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement. | B |
| 7 | Colon Computed Tomography System, Computer Aided Detection | To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review. | B |
| 8 | Lung ComputedTomographySystem, ComputerAided Detection | To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. | B |
| 9 | Chest X-Ray Computer Aided Detection | To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review | B |
| 10 | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). | B |
| 11 | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | X-ray angiographic imaging based coronary vascular simulation software device is a device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. And yields simulation-based metrics for certain cardiology applications which aid clinical user. | B |
| 12 | Automated Radiological Image Processing Software | To provide automated radiological image processing and artificial intelligence based analysis tools. | B |
| 13 | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. | B |
| 14 | Chairside dental CAD/CAM unit | Intended for computer-aided design (CAD) or computer-aided manufacturing (CAM) of dental restorations. | B |
| 15 | Software for using with mammographycombined diagnostic X-ray system | A software, which is designed to processes data obtained from a combined diagnostic mammographyradiography system. | B |
| 16 | Software for public thoracic and abdominal health screening diagnostic X-ray system | A software, which is designed to process data obtained from a thoracic and abdominal public health screening diagnostic X-ray system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software are stored. | B |
| 17 | Software for visual evoked response stimulator | A software, which is designed to process data obtained from a visual evoked response stimulator. The resultant data are provided for diagnosis, etc. | B |
| 18 | Software for auditory evoked response stimulator | A software for medical device, which is designed to process data obtained from an auditory evoked response stimulator. The resultant data are provided for diagnosis, etc. | B |
| 19 | Software for pulmonary exercise stress monitoring system | A software, which is designed to process data obtained from a pulmonary exercise stress monitoring system. | B |
| 20 | Software for ECG recorder with realtime analysis | A software, which is designed to process data obtained from an ECG recorder with real-time analysis. The resultant data are provided for diagnosis, etc. | B |
| 21 | Software for filmrecorded digital radiography | A software, which is designed to process data obtained from a film-recorded digital radiography. The resultant data are provided for diagnosis, etc. | B |
| 22 | Software for dye dilution cardiac output calculator | A software, which is designed to process data obtained from a dye dilution cardiac output unit. The resultant data are provided for diagnosis, etc. | B |
| 23 | Software for urodynamic measurement system | A software, which is designed to process data obtained from a urodynamic measurement system. The resultant data are provided for diagnosis, etc. | B |
| 24 | Software for vestibular function caloric stimulator | A software, which is designed to process data obtained from a vestibular function caloric stimulator. The resultant data are provided for diagnosis, etc. | B |
| 25 | Surporting software for external fixators treatment plan | A software that analyzes information useful for bone fracture and for correction of bone deformities based on information collected from diagnostic X-ray systems, etc. or based on information entered in a therapeutic apparatus, and supports preparation of a treatment plan with external fixators. | B |
| 26 | Diagnostic supporting software for diabetes | A software that supports analysis and assessment of therapeutic effects of diabetes treatment by processeing information collected from a blood glucose meter, etc into the data related to changes or trends in blood glucose levels. | B |
| 27 | Quantitative calculation software for IGC test | A software that performs quantitative calculation of blood flow in relation to a brightness time change based on information obtained from video images of indocyanine green angiography. | B |
| 28 | Analyzing software for hemodynamics or cardiac function | A medical device program that analyzes hemodynamics or cardiac function based on information obtained from diagnostic imaging systems, etc. and uses the results for diagnosis. | B |
| 29 | Supporting software for root canal treatment | A software for medical device, which is used to support preparation of a treatment plan based on information collected from diagnostic imaging systems, etc. in the root canal treatment. | B |
Site Reference List – http://cdscomdonline.gov.in/
Process To Apply for Class B Medical Devices Registration
Classify the medical devices according to CDSCO instructions – Classify the medical device then collect all the required papers for the
Provide application on the CDSCO Portal – After preparing the documents apply on the CDSCO online portal.
Review by CDSCO – CDSCO will review your submitted application and verify whether your medical device are safe or not.
Approval and Denial – After analysing your product and application decision will be made.
If you want to apply for the medical device certificate you can directly click on it.
Required Items for Class B Medical Devices Registration
When you are registering for medical device, there are many documents are needed but here are the important items required for the medical device registration:-
- Do follow the indian laws and rules
- CDSCO fees
- Manufacturing facility information
- Regulatory certification for example – free sale certificate, ISO 13485, and etc.
Who are Eligible to Apply Class B Medical Devices Registration?
List is mentioned below please check, to know who are eligible for the Medical device registration:-
- Cosmetic, IVD’s, Importers of medical devices
- IVD’s and Indian Subsidairy of medical devices
- IVD’s and Domestic manufacturers of medical devices
- IVD’s and Authorized agent of medical devices
- IVD’s and Forign agent of medical devices
What are Class B Medice Devices?
Class – B medical devices are moderate in risk as compare to class – c and d, and easy to apply. State licensing authority approves the Class – B Medical devices.
What is Class A Medical Device?
Class – A medical devices are low in risk as compare to class – b medical devices and class – c medical devices.
Are Dialysis Machines Class 3?
Dialysis machines are medical devices and because of their degree of danger are viewed as Class II in light of rule 3.
What is Type B Medical Equipment?
Class – B medical devices are made to handle patient, but without making direct contact with the deceased.