If you are confused about what are Class C medical devices then here is your answer, Class C medical devices are moderate to high risk. As this category of medical devices comes in contact with the body for more time than the other two classes “Class – A & B” of medical devices that’s why this are bit too serious and dangerous. All the Class C Medical Devices are mentioned below.
List Of Class C Medical Devices
Here you can explore the Class C medical devices list and check which certification do you need to apply for the specific product.
Category – Anesthesiology
A list of Class C Medical Devices under the category of Anesthesiology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Anesthesia machine | A medical device is used to generate and mix a fresh gas flow of medical gases and inhalational anaesthetic agents to induce, monitor, and maintain anaesthesia. | C |
| 2 | Airway pressure/oxygen monitor | It is a device intended 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. | C |
| 3 | Anesthesia vaporizer | A device used to vaporize the anesthetic agent and deliver a controlled amount of the agent to a patient being prepared for surgery. | C |
| 4 | High-frequency ventilator | A device intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. | C |
| 5 | Intravascular membrane oxygenator | A device designed for intravascular diffusion of oxygen into and carbon dioxide from the blood across an implantable (vena cava) gas-permeable membrane, used mainly as a temporary treatment for failing lungs in adults with respiratory distress syndrome. | C |
| 6 | Manual jet ventilation device | A portable, manually-operated, noninvasive device intended to be used in conjunction with a separate compressed oxygen (O2) source and airway access device for transtracheal ventilation of a patient in an emergency situation where there is complete or partial obstruction of the airways. | C |
| 7 | Negative-pressure ventilator | An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs | C |
| 8 | Oxygen/air/nitrous oxide breathing gas mixer | An device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing | C |
| 9 | Patient physiologic monitoring system | An assembly of devices designed for continuous assessment of several vital physiologic parameters of patient(s) | C |
| 10 | Pulmonary resuscitator | A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. | C |
| 11 | Pulse oximeter | A device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2) | C |
| 12 | Tracheostomy kit | A collection of surgical instruments, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation | C |
Category – Pain Management
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Analgesic peripheral nerve electrical stimulation system | An assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain | C |
| 2 | Analgesic spinal cord electrical stimulation system | An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). | C |
| 3 | Cryogenic analgesia unit | A device designed to provide analgesia by applying extremely low temperatures to body tissues. It is used for postoperative and chronic intractable pain relief. | C |
| 4 | Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system | An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. | C |
| 5 | Epidural anaesthesia kit | A collection of devices intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. | C |
| 6 | Epidural/intrathecal anaesthesia kit | A collection of devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. | C |
| 7 | Flexible fibreoptic epiduroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain. | C |
| 8 | Medium-wave diathermy treatment system | An assembly of devices designed 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. ,to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | C |
| 9 | Microwave diathermy treatment system | An assembly of devices designed to produce a therapeutic heat below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, to promote tissue healing and pain relief. | C |
| 10 | Multi-modality physical therapy system | An assembly of devices designed to apply multiple different energies either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders. | C |
| 11 | Musculoskeletal intense therapeutic ultrasound system | An assembly devices designed to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues, intended to reduce inflammation and pain associated with musculoskeletal disorders or injuries by stimulating collagen production and regenerating connective tissue | C |
| 12 | Musculoskeletal/physical therapy laser | An electrically-powered diode laser intended to provide noninvasive laser therapy for localized treatment of musculoskeletal conditions, improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. | C |
| 13 | Neurophysiologic monitoring system | An assembly of devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction | C |
| 14 | Transcutaneous ElectroNeuro Stimulator (TENS) devices | A therapy device intended to stimulate the nerves for pain relief | C |
Category – Cardiovascular
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Arrhythmia Detector And Alarm (Including StSegment Measurement And Alarm). | The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs | C |
| 2 | Electrocardiograph electrode. | An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. | C |
| 3 | Intra-aortic balloon and control system. | An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain lifethreatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle. | C |
| 4 | Pacing system analyzer. | A pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester (870.3720) and an external pacemaker pulse generator (EPPG) (870.3600). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing lead | C |
| 5 | Pacemaker lead adaptor. | A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer. | C |
| 6 | Annuloplasty ring. | An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. | C |
| 7 | Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure | An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient’s blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors). | C |
| 8 | Cardiopulmonary bypass defoame | A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood. | C |
| 9 | Cardiopulmonary bypass arterial line blood filter. | A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. | C |
| 10 | External cardiac compressor. | An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). | C |
| 11 | External transcutaneous cardiac pacemaker | An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles | C |
Category – Dental
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Dental bone matrix implant, animalderived | A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. | C |
| 2 | Carboxymethylcellul ose sodium denture adhesive | An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. | C |
| 3 | Carboxymethylcellul ose sodium/polymer denture adhesive, zinc-free | An adhesive compound intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. | C |
| 4 | Dental amalgam | A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). | C |
| 5 | Dental amalgam alloy | A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. | C |
| 6 | Dental amalgam mercury | Elemental mercury (Hg) of high purity intended for use as a component of dental amalgam in the restoration of a dental cavity or broken tooth | C |
| 7 | Temporary mandibular condyle prosthesis | A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. | C |
| 8 | Temporomandibular joint disc | A sterile interpositional implant or interarticular disc, intended to permanently interface between the natural mandibular condyle and natural glenoid fossa (mandibular fossa) in the temporomandibular joint (TMJ). | C |
| 9 | Transgingival implant | A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis | C |
| 10 | Transmandibular implant | A sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. | C |
| 11 | Pliable-polymer dental regeneration membrane, bioabsorbable, ligated | A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the downgrowth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. | C |
| 12 | Pliable-polymer dental regeneration membrane, bioabsorbable, tacked | A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the downgrowth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. | C |
| 13 | Dental surgical procedure kit, medicated, reusable | A collection of various dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure. | C |
| 14 | Dental surgical procedure kit, medicated, singleuse | A collection of various sterile dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure | C |
| 15 | Membrane fixation tack, bioabsorbable | A sterile bioabsorbable tack intended to be used to fix a pliablepolymer dental regeneration membrane in situ to aid in the regeneration of tooth support that has been lost due to periodontal disease or trauma. | C |
| 16 | Periodontal root surface regeneration material | A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which reestablishes the lost tooth support. | C |
| 17 | Periodontal tissue reconstructive material | A sterile viscous material intended to be injected into the buccal mucosa to treat deficiencies of the gingiva (e.g., interdental papillae), through augmentation, during the treatment of intermediate stage periodontal disease | C |
| 18 | Bone matrix implant, humanderived | A sterile implantable device made primarily of human demineralized bone matrix (DBM) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. | C |
| 19 | Collagen dental regeneration membrane | A sterile, bioabsorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and/or to regenerate bone or bone defects around dental implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. | C |
| 20 | Dental anaesthesia system | An assembly of devices used for the administration of a proportional mixture of oxygen (O2) and nitrous oxide (N2O) or medical air during dental surgical treatment. | C |
| 21 | Calcium hydroxide dental cement | 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 calcium hydroxide and salicylic acid . | C |
| 22 | Dental soft-tissue matrix implant, animal-derived | A sterile, bioabsorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device. | C |
Category – ENT
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Anchored bone-conduction hearing implant system | Intended to treat hearing impairment due to middle and/or outer ear obstructive pathologies or types of conductive hearing loss | C |
| 2 | Auditory stimulator | Intended to apply sound stimuli to a patient’s acoustic system | C |
| 3 | Behind-the-ear boneconduction tinnitus masker | Intended to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus | C |
| 4 | Cochlear implant assessment system | Intended to perform an integrity test on the implantable portion of a cochlear implant (CI) system insitu. | C |
| 5 | Ear prosthesis | Intended to reconstruct the external ear by replacing damaged or missing tissue. | C |
| 6 | Ossicular prosthesis, partia | Intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones). | C |
| 7 | Middle ear mold | A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. | C |
| 8 | Fully-implantable middle ear implant system | An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device | C |
| 9 | Larynx prosthesis | A device used for replacement and restoration of the laryngeal function, or for maintenance of patency of the larynx. | C |
| 10 | Ossicular prosthesis, total | A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ea to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease | C |
| 11 | Ear, nose, and throat electric or pneumatic surgical drill | An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur , for the controlled incision or removal of bone in the ear, nose, and throat area. | C |
| 12 | Argon laser for otology, rhinology, and laryngology | Device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue while performing ENT surgical procedure. | C |
| 13 | Ear, nose, and throat microsurgical carbon dioxide laser | Device intended for the surgical excision of tissue from the ear, nose, and throat area while performing microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas. | C |
| 14 | Suction antichoke device | A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient’s airway to prevent asphyxiation to the patient | C |
| 15 | Tongs antichoke device | A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient’s airway to prevent asphyxiation of the patient. | C |
| 16 | External upper esophageal sphincter compression device | An external upper esophageal sphincter compression device is intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease | C |
| 17 | Active implantable bone conduction hearing system | The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. | C |
| 18 | Partial ossicular replacement prosthesis | A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. | C |
| 19 | Total ossicular replacement prosthesis | A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. | C |
| 20 | Mandibular implant facial prosthesis | A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. | C |
| 21 | Sacculotomy tack (Cody tack) | A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended to be implanted to relieve the symptoms of vertigo. | C |
| 22 | Tympanostomy tube with semipermeable membrane | A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. | C |
| 23 | Transcutaneous air conduction hearing aid system | A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal | C |
| 24 | Gustometer | A gustometer is a battery-powered device that consists of two electrodes that are intended to provide galvanic stimulus resulting in taste sensation. | C |
Category – Gastroenterology
A list of Class C Medical Devices under the category of Gastroenterology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Anal fistula seton | A sterile implantable cord intended to be placed through an anal fistula tract and tied outside the fistula, forming a loop around the anus, to allow drainage through the fistula for tissue healing | C |
| 2 | Bile duct prosthesis | An implantable artificial substitute for the tube-like structure that carries bile from the gallbladder to the duodenum. | C |
| 3 | Biliary drainage catheter | A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. | C |
| 4 | Colonic mucosa barrier dressing | A non-sterile solution/suspension intended to be introduced into the sigmoid/descending colon as an enema for the treatment of inflammatory bowel disease (e.g., ulcerative colitis). It is intended to create an adhesive physical barrier on the colonic mucosa to protect the mucosa from potentially harmful substances in the distal colon lumen | C |
| 5 | Duodenal bypass liner | A non-sterile stent-like device with a valve designed to be implanted in the duodenum where it is intended to reduce duodenal nutrient absorption from food to facilitate obese patient weight loss. | C |
| 6 | Duodenal-jejunal bypass liner | A sterile stent-like implant designed to function as an impermeable barrier in the duodenum and part of the jejunum for partially-digested food from the stomach (chyme) passing on its inside and bile/digestive enzymes passing on its outside, intended to treat type 2 diabetes mellitus and obesity. | C |
| 7 | Enteral feeding kit, adult/paediatric, non-sterile | A collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump | C |
| 8 | Enteral feeding kit, adult/paediatric, sterile | A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. | C |
| 9 | Enteral feeding tube clearing kit | A collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency | C |
| 10 | Gastric sleeve | A sterile implantable device intended to be wrapped around the proximal portion of the stomach to reduce stomach volume and facilitate weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed through an increased sense of satiety (fullness). | C |
| 11 | Gastrointestinal anastomosis coupler, non-bioabsorbable | An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. | C |
| 12 | Gastrointestinal endoscopic clip, longterm | A sterile clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects | C |
| 13 | Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. | C |
| 14 | Gastrojejunostomy tube | A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. | C |
| 15 | Gastro-oesophageal antireflux prosthesis | An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. | C |
| 16 | Gastrostomy aspiration system gravity set | A collection of non-sterile devices designed as the external portion of a gastrostomy aspiration system intended to be used post-surgery by the patient after implantation of the stomach tube for the removal of a portion of stomach contents after meals, by aspiration, to achieve portion control and subsequently weight loss in a morbidly obese (bariatric) patient (≥ 18 years) | C |
| 17 | Gastrostomy aspiration system stomach tube | A sterile, thin, flexible, hollow cylinder intended to be percutaneously implanted by endoscopic methods into the stomach of a morbidly obese (bariatric) patient (≥ 18 years) for the removal of a portion of stomach contents after meals by aspiration when used with a dedicated gravity kit that is the external portion of a gastrostomy aspiration system. | C |
| 18 | Gastrostomy button | A sterile, short, tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. | C |
| 19 | Gastrostomy T fastener | A device intended to be inserted into the stomach percutaneously to appose the anterior gastric wall to the anterior abdominal wall, typically to facilitate the insertion of a percutaneous gastrostomy tube or for procedures requiring stabilization/fixation of hollow gastrointestinal (GI) structures. | C |
| 20 | Gastrostomy tube | A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine | C |
| 21 | Implantable gastric clamp | A sterile implantable device designed to isolate the lesser curvature segment of the stomach (magenstrasse) to reduce stomach volume and facilitate weight loss in overweight/obese patients through a reduction in food consumption based on an increased sense of satiety (fullness). | C |
| 22 | Implantable incontinence-control electrical stimulation system | An assembly of battery-powered devices intended to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. | C |
| 23 | Implantable peritoneal catheter holder | A small, sterile, implantable device designed to secure a peritoneal or lumboperitoneal catheter in situ by suturing it to the abdominal fascia at the point of entry/exit. | C |
| 24 | Intestinal splint | A sterile rigid or flexible device intended to be implanted within the abdomen to stabilize a portion of the intestine, or to stabilize and protect an injured portion of the intestine. | C |
| 25 | Jejunostomy tube | A sterile, thin, flexible, hollow cylinder percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine | C |
| 26 | Nasoenteral tube | A sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. | C |
| 27 | Non-vascular catheter introduction set | A collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter). | C |
| 28 | Oesophageal tube | A sterile, hollow cylinder that usually contains two balloons, one for the stomach and one for the oesophagus, which are inflated after the device has been inserted into the oesophagus to tampon bleeding oesophageal varices | C |
| 29 | 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. | C |
| 30 | Partially-implantable abdominal port/catheter | A sterile partially-implantable device intended to provide access to the peritoneal cavity for infusion (e.g., insulin, chemotherapeutic agents) | C |
| 31 | Pharyngeal electrical stimulation catheter | A sterile, flexible tubular device intended to deliver pharyngeal electrical stimulation for the treatment of neurogenic dysphagia. | C |
| 32 | Probiotic oropharyngeal mucosa dressing | A non-sterile substance intended to be applied to the mucosa of the mouth and/or pharynx to facilitate saprophytic microflora colonization within the oral cavity/pharynx, typically following antibiotic therapy, bacterial infection, or injury. It includes probiotic bacteria (e.g., Streptococcus salivarius, Streptococcus oralis) and compounds that create a barrier to facilitate growth of the probiotic bacteria | C |
| 33 | Robotic electrosurgical instrument, bipolar, single-use | A sterile electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. | C |
| 34 | Stoma support implant | A sterile, non-bioabsorbable device intended to be implanted into the abdominal wall during a gastro-urological ostomy procedure to reduce the risk of parastomal hernia by supporting the abdominal wall surrounding the stoma. | C |
| 35 | Thermal-regulation orogastric tube | A non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) thermal regulation of the whole body via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature). | C |
| 36 | Transenteric drainage tube | A sterile non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. | C |
Category – Urology
A list of Class C Medical Devices under the category of Urology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Bare-metal urethral stent, short-term | A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). | C |
| 2 | Electromechanical lithotripsy system, extracorporeal | An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. | C |
| 3 | Hydraulic male urinary incontinence treatment system | An assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate. | C |
| 4 | Hydraulic male urinary incontinence treatment system port | An implantable component of a hydraulic male urinary incontinence treatment system intended to provide access to the system’s inflatable pad (e.g., cushion, balloon), for the intraand/or postoperative introduction/removal of fluid (e.g., saline). | C |
| 5 | Hydraulic male urinary incontinence treatment system tubing | An implantable length of tube that functions as a component of a hydraulic male urinary incontinence treatment system and intended to provide connection between the system’s inflatable pad (e.g., cushion, balloon) and the system’s port, for the intraand/or postoperative introduction/removal of fluid (e.g., saline); it is typically made of silicone and metal. | C |
| 6 | Hydraulic male urinary incontinence treatment system tubing plug | An implantable component of a hydraulic male urinary incontinence treatment system intended to seal the system’s tubing to prevent spillage/leakage of its contents when introduction/removal of fluid to/from the system’s pad (e.g., cushion, balloon) is not needed; it is typically made of metal. | C |
| 7 | Inflatable penile prosthesis | An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse | C |
| 8 | Laser lithotripsy fibre/suction guide | A sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy 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), and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. | C |
| 9 | Laser lithotripsy system | An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). | C |
| 10 | Microwave hyperthermia system catheter, prostatic-ablation, reusable | A thin rod intended to be used as part of a hyperthermia system to treat disorders of the prostate [e.g., cancer, benign prostatic hyperplasia (BPH), prostatitis] through the local application of heat from microwaves | C |
| 11 | Perineal orifice incontinence-control electrical stimulation system, remote control | An assembly of battery-powered, remote-controlled devices designed for intravaginal pelvic floor exercise to treat urinary incontinence and other pelvic problems in women (e.g., pelvic pain and sexual dysfunction) through the application of electrical stimuli to the muscles of the pelvic floor. | C |
| 12 | Piezoelectric 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 piezoelectric generator. | C |
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Category – General Hospital
A list of Class C Medical Devices under the category of General Hospital is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Electronic monitor for gravity flow infusion systems | Inteded to electroncially monitor the amount of fluid being infused into a patient. | C |
| 2 | Infant radiant warmer. | Intended to be placed over an infant to maintain the infant’s body temperature by means of radiant heat. | C |
| 3 | Neonatal incubator. | A neonatal incubator is a device in which an infant may be kept in a controlled environment (humidity, temperature, oxygen etc) for medical care. | C |
| 4 | Neonatal transport incubator. | Transport incubator is a device in which an infant may be kept in a controlled environment (humidity, temperature, oxygen etc) while being transported for medical care. | C |
| 5 | Jet lavage | A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. | C |
| 6 | Infusion pump. | An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner | C |
| 7 | Chemical cold pack snakebite kit. | Intended for first-aid treatment of snakebites | C |
| 8 | Ingestible event marker. | An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial | C |
| 9 | Ultraviolet (UV) radiation chamber disinfection device. | An ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of nonporous medical device surfaces by dose-controlled UV irradiation. | C |
| 10 | Ethylene oxide gas sterilizer. | Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices. | C |
| 11 | Dry-heat sterilizer. | A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical devices by means of dry heat | C |
| 12 | Steam sterilizer. | A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical devices by means of pressurized steam. | C |
| 13 | Liquid chemical sterilants/high level disinfectants. | A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. | C |
| 14 | Wheeled stretcher. | A wheeled stretcher is a device intended to transport patients in a horizontal position as an assistance to injury or disability. | C |
| 15 | Medical washer-disinfector. | A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices | C |
| 16 | Hydrogen Peroxide Gas Plasma Sterilization System | Intended for sterilization/disinfection of both metal and nonmetal/polymer based medical devices. | C |
| 17 | Environmental chamber for storage of platelet concentrate | A refrigerated environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range | C |
| 18 | Blood storage refrigerator | Thsese are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures. | C |
| 19 | Automated blood cell separator | The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further clinical use. | C |
Category – Operation Theatre
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | General-purpose electrosurgical unit | A unit used to resect/ablate the tissue or to coagulate the incision/wound site with high-frequency waves. | C |
| 2 | Long-term use enterostomy feeding tube | A hollow device to be placed surgically in the stomach, duodenum or jejunum to provide enteral nutrition. It is for long-term use. | C |
| 3 | Gastrostomy tube for long-term use | A hollow device to be placed surgically in the stomach, duodenum or jejunum for enteral nutrition, etc. It is for long-term use. | C |
| 4 | Warming high-flow infusion pump | A device to be used for heating and rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries | C |
| 5 | High-flow blood transfusion pump | A device to be used for rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries. | C |
| 6 | Multiparameter monitor with critical parameters | A unit that collects monitoring parameters (include an electrocardiogram (ECG), blood pressure, body temperature, cardiac output, and respiratory gases; in addition, other critical parameters (supporting detection of arrhythmia or apnea; and in the case of anesthesia, determination of dose levels of a relaxant or local anaesthesia) using an embedded function kit, module, or other devices to display data, by bed or by patient. | C |
| 7 | Surgical robot unit | An operation support device used in open surgery or endoscopic surgery that performs treatment of tissues including suturing, detaching and severing, and installing a prosthesis | C |
Category – Respiratory
A list of Class C Medical Devices under the category of Respiratory is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Artificial airway washing/disinfection jar | A container intended to hold artificial airway devices to facilitate their washing/disinfection. | C |
| 2 | Breathing circuit washer/disinfector | A device intended for the cleaning and high-level disinfection of breathing circuit components used in respiratory therapy and anaesthesia equipment. | C |
| 3 | Hyperbaric chamber | The intended use of the Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient. | C |
| 4 | Negative-pressure ventilato | An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs | C |
| 5 | Pulse oximeter | A device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2) | C |
| 6 | Therapeutic positive pressure breathing ventilator | A device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patient’s airways and lungs | C |
| 7 | Thoracic electrical impedance tomography system | An assembly of devices designed to perform continuous bio-impedance measurements throughout a cross-section of the thorax, to provide realtime feedback of lung function of a ventilated patient. | C |
Category – Neurological
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Autonomic neuropathy heart rate meter | Intended to diagnose autonomic nervous system dysfunction (autonomic neuropathy) | C |
| 2 | Behavioural therapy electrical stimulation system | Intended in the treatment of obsessive/compulsive behaviour and drug abuse, by applying electrical impulse(aversion therapy). | C |
| 3 | Brain injury adjunctive interpretive electroencephalograph assessment aid. | A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis | C |
| 4 | Computerized cognitive assessment aid. | The computerized cognitive assessment aid is a prescription device that uses an individual’s score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine the level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device | C |
| 5 | Craniotomy power tool system handpiece | Intended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or perforator) in order to produce a hole or holes in the skull vault (calvarium). | C |
| 6 | Cutaneous electrode. | A cutaneous electrode is an electrode that is applied directly to a patient’s skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation | C |
| 7 | Deep brain electrical stimulation system lead | Intended to be implanted in specific areas of the deep brain and used along with a deep brain electrical simulation system. | C |
| 8 | Depth electrode | A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain | C |
| 9 | Diagnostic peripheral nerve electrical stimulation system | Intended to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. | C |
| 10 | Dura mater sealant | Intended to be applied to sutured dura mater to prevent cerebrospinal fluid (CSF) leakage during healing | C |
| 11 | Echoencephalograph | An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head | C |
| 12 | Ejaculation electrical stimulation system | Intended to apply electrical stimuli to the nerves that control ejaculation. | C |
| 13 | Electroconvulsive therapy system | Intended to apply strong electrical stimuli to a patient’s brain to induce convulsions and loss of consciousness, typically to treat major depression, schizophrenia, or mania | C |
| 14 | Electroencephalograph. | An electroencephalograph is a device used to measure and record the electrical activity of the patient’s brain obtained by placing two or more electrodes on the head | C |
| 15 | Electroencephalographic monitoring system | Intended to continuously measure the electrical signals produced by a patient’s brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. Alongwith which measuring of other physiological parameters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. | C |
| 16 | Epicranial brain electrical stimulation system | Intended to apply weak, pulsed (not continuous) electrical stimuli from beneath the scalp to specific areas of the brain for the treatment of focal epilepsy | C |
| 17 | Home seizure monitoring system | Intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. | C |
| 18 | Implantable lumbar neuromuscular electrical stimulation system programmer | Intended to be used by a healthcare professional to telemetrically program the implantable ( lumbar neuromuscular electrical stimulation system) pulse generator component with patient-specific parameters. | C |
| 19 | Implantable sleep apnoea treatment system programmer/charger | Intended to be used by the patient to communicate telemetrically with an implanted pulse generator to control therapy, and recharge the pulse generator’s battery. | C |
| 20 | Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer | Intended to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG) | C |
| 21 | Intranasal cooling system | Intended for rapid cooling induction in patients where temperature reduction is clinically indicated (e.g., following a cerebral ischemic event, during cardiac arrest) to help mimimize damage to the brain and heart | C |
| 22 | Intranasal lacrimal neurostimulator | Intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as a treatment for aqueous deficient dry eye. | C |
| 23 | Invasive-detection physiological monitor | Intended for continuous or intermittent measurement, display and/or recording of several invasively-detected physiological parameters [e.g., intracranial pressure (ICP), compartmental pressure]. | C |
| 24 | Nasopharyngeal electrode. | A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity | C |
| 25 | Needle electrode. | A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals | C |
| 26 | Nerve conduction velocity measurement device. | A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient’s peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time | C |
| 27 | Neurological endoscope | A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain | C |
| 28 | Neurological stereotactic surgery system | Intended to store diagnostic images used for image-guided neurosurgery | C |
| 29 | Neuromuscular transmission electrical skin sensor | Intended to detect electrical neuromuscular transmission (NMT) signals, for assessing the degree of neuromuscular block in a patient | C |
| 30 | Neuropsychiatric interpretive electroencephalograph assessment aid. | The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient’s electroencephalograph (EEG) to provide an interpretation of the patient’s neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis | C |
| 31 | Non-electroencephalogram (EEG) physiological signal-based seizure monitoring system | A non-electroencephalogram (non-EEG) physiological signal-based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure | C |
| 32 | Olfactometry system | Intended to determine the response of humans to odours delivered through the nose, including irritants. | C |
| 33 | Photodiode subretinal prosthesis system | Designed to provide visual function to a patient with vision loss due to retinal degeneration by detecting light, converting it into electrical signals, and relaying them to the retina for neural stimulation | C |
| 34 | Scalp clip | A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp | C |
| 35 | Spinal needle bioimpedance navigation unit | Inteded to transmit and receive electrical signals to/from a dedicated spinal needle (which doubles as a bipolar electrode) and to analyse bioimpedance data in real-time, to predict needle tip location [including confirmation of contact with cerebrospinal fluid (CSF)]. | C |
| 36 | Stereotactic neuronavigation/planning system | Intended to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments | C |
| 37 | Vagus nerve electrical stimulation system programmer | The strength and duration of the electrical impulses are programmed | C |
Category – Obstetrical and Gynecological
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Abdominal decompression chamber | Non- invasive medical device placed at abdomen to alleviate abdominal pain during pregnancy or delivery | C |
| 2 | Abdominal decompression chamber pump | A dedicated pump used with hood-like device to control and reduce abdominal pressure of a pregnant women. | C |
| 3 | Cardiotocograph | A device that records fetal heart rate and uterine contraction simultaneously. | C |
| 4 | Cardiotocograph transducer | A device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals. | C |
| 5 | Cardiotocography telemetric monitoring system | An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a monitor. | C |
| 6 | Cardiotocography telemetric monitoring system receiver | A part of wireless telemeter system. It receives signals from transmitter that senses fetal heart rate and uterine contraction during labor. | C |
| 7 | Cardiotocography telemetric monitoring system transmitter | It transmits signals related to fetal heart rate and uterine contractions to the receiver | C |
| 8 | Contraceptive cervical cap, reusable or single use | Device inserted into the cervix to prevent semen from enterig the uterus. | C |
| 9 | Contraceptive spermicide | A chemical substance (e.g., nonoxynol-9) intended to be introduced with an applicator or the finger into the vagina before sexual intercourse, to destroy sperm (spermatozoa) to prevent pregnancy. | C |
| 10 | Contraceptive sponge | Bubble like device works as a physical barrier to prevent spermatic invasion into uterus. | C |
| 11 | Diaphragm pessar | A circular device placed in the vagina prior to intercourse to mechanically prevent conception. | C |
| 12 | Foetal bladder shunt | A sterile non-bioabsorbable tubular device implanted in the bladder of a foetus with postvesicular obstructive uropathy, to decompress the urinary tract for urine to pass from bladder into the amniotic sac, until the defect can be surgically repaired after birth | C |
| 13 | Foetal cardiac monitor | An active device designed to detect, measure, and display fetal heart activity during the perinatal period | C |
| 14 | Foetal pleuro-amniotic catheter | Sterile implantable device used to contineously drain fetal pleural effusion to maternal amniotic cavity. | C |
| 15 | Foetal scalp electrode, clip | Placed directly on the scalp of the fetus in the uterus to monitor fetal vital signs | C |
| 16 | Breast transilluminator | Active device transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. | C |
Category – Ophthalmic
A list of Class C Medical Devices under the category of Ophthalmic is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Capsular bag anchor | A device intended to be permanently implanted in the posterior chamber of the eye for correction and fixation of a subluxated capsular bag, typically in association with in-the-bag intraocular lens (IOL) implantation. | C |
| 2 | Contact lens agitation cleaning system | An assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation . | C |
| 3 | Contact lens disinfecting solution | An aqueous formulation containing appropriate agents for loosening debris from contact lenses, and that contains a disinfectant intended to act on contact lens. | C |
| 4 | Contact lens protein-removal solution | A formulation of proteolytic enzymes, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. | C |
| 5 | Contact lens thermal cleaner | A unit intended to disinfect or sterilize reusable soft contact lenses by means of heat. | C |
| 6 | Corneal inlay, aperture reducing | A implantable device inserted into the natural cornea to treat presbyopia based on aperture reduction. | C |
| 7 | Corneal inlay, corneareshaping | A implantable device inserted into the natural cornea to treat refractive errors by reshaping the cornea. | C |
| 8 | Donor cornea container | A receptacle intended to maintain, transport, and facilitate clinical examination of a donated cornea during the period between cornea collection and transplantation surgery. | C |
| 9 | Endoscopic-imaging ophthalmic solid-state laser system | A device assembly intended to treat retinal and other eye disorders, such as glaucoma, during endoscopic cyclophotocoagulation (ECP) procedures | C |
| 10 | Eye muscle sleeve | An implantable device made from synthetic materials that is used to encase or isolate an ocular muscle. | C |
| 11 | Eye valve | An implantable device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value | C |
| 12 | Eyelid weight, implantable | An ophthalmic device that is implanted subcutaneously within the upper eyelid to “lidload” the eyelid to restore upper eyelid muscle function. | C |
| 13 | Femtosecond ophthalmic solid laser system | A device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions | C |
| 14 | Fundus-imaging ophthalmic diode laser system | Intended for: ocular laser treatment procedures, including the coagulation of abnormal retinal vasculature; and capturing real-time digital images of the anterior/posterior eye segments created using color, fluorescein angiography, and infrared imaging, for diagnosis/treatment planning. | C |
| 15 | Fundus-imaging ophthalmic solid-state laser system | Intended to coagulate abnormal vascular tissue in the retina and for other ocular photocoagulation procedures. | C |
| 16 | Glaucoma supraciliary implant | A non-bioabsorbable synthetic polymer device designed to be implanted in the supraciliary space (between the ciliary muscle/body and the sclera) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. | C |
| 17 | Glaucoma therapy ultrasound system | A system designed to transduce radio-frequency (RF) electrical energy from a generator into ultrasound energy, for the extracorporeal application of high intensity focused ultrasound (HIFU) to the eye, to decrease aqueous humour production and reduce intraocular pressure (IOP) | C |
| 18 | Implantable intraocular pressure monitoring system | An assembly of portable devices intended to continuously or regularly collect and display intraocular pressure (IOP) data for the diagnosis/monitoring of glaucoma. | C |
| 19 | Implantable iris prosthesis | An optical device intended to be implanted into the posterior chamber of the eye for the reconstruction of partial or total iris defects. | C |
| 20 | Intracorneal ring | An implantable, open-ended circular band designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct mild and moderate myopia | C |
| 21 | Intranasal lacrimal neurostimulator | A hand-held device intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. | C |
| 22 | Intraocular pressure-reducing system | An assembly of manually operated devices designed to reduce the intraocular pressure (IOP) by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. | C |
| 23 | Ophthalmic clip | A device typically made of a malleable metal (e.g., tantalum), intended to be implanted permanently or temporarily to bring together the edges of a wound, to aid in healing or to prevent bleeding from small blood vessels in the eye | C |
| 24 | Ophthalmic cryosurgical system | An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) to a target tissue for its destruction and removal during an ophthalmic surgical procedure | C |
| 25 | Ophthalmic dye laser system | A laser device assembly intended to coagulate abnormal vascular tissue in the retina, and for other photocoagulation procedures in the eye. | C |
| 26 | Ophthalmic noble gas laser system | A laser device assembly intended to coagulate abnormal vascular tissue in the retina and for other photocoagulation procedures in the eye. | C |
| 27 | Ophthalmoscope | An ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media | C |
| 28 | Orbital rim prosthesis | An implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves and is intended to house an artificial eye. | C |
| 29 | Phacoemulsification system | An assembly of ophthalmic devices intended to deliver energy through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification. | C |
| 30 | Ptosis sling | A sterile implantable device intended for the surgical correction of ptosis. | C |
| 31 | Retinal tack | A non-bioabsorbable, implantable device designed to permanently fix a detached retina to the underlying retinal pigment epithelium (RPE) during ophthalmic surgery. | C |
| 32 | Scleral buckling device | A device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment. | C |
| 33 | Scleral expansion implant | A device designed for implantation in the sclera to produce expansion by altering the position of the underlying ciliary muscle. | C |
| 34 | Symblepharon ring | An implantable device formed as a circular band is used to help prevent the eyelid from adhering to the eyeball. | C |
| 35 | Vitrectomy system | An assembly of ophthalmic devices intended to deliver energy through a dedicated hand-held instrument, typically used to treat diabetic vitreous hemorrhage, retinal detachment, epiretinal membrane, and macular hole. | C |
| 36 | Vitreous body prosthesis | A sterile bag/capsule intended to be implanted in the eye and filled with a fluid (not included) to replace the vitreous body and provide omnidirectional support of the retina for the treatment of severe retinal detachment. | C |
Category – Rehabilitation
A list of Class C Medical Devices under the category of Rehabilitation is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Electromechanical orthopaedic extracorporeal shock wave therapy system | Intended to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. | C |
| 2 | Foot sensorimotor therapy mechanical neurostimulator | Intended to provide noninvasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders (e.g., Parkinson’s disease). | C |
| 3 | Interferential electrical stimulation system | Intended 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. | C |
| 4 | Musculoskeletal intense therapeutic ultrasound system | Intended to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons). | C |
| 5 | Musculoskeletal/ physical therapy laser | Intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for nonneedle acupuncture. | C |
| 6 | Pulsed signal therapy system | Intended to regenerate damaged cartilage, particularly by stimulating the production of collagen types that are present in healthy cartilage. | C |
| 7 | Short-wave diathermy treatment system | Intended 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 of 13 megahertz (MHz) to 27.12 MHz. | C |
| 8 | Therapeutic nuclear magnetic resonance system | Intended to influence cellular metabolism using nuclear magnetic resonance (NMR) for the treatment of degenerate and pathological changes to the movement/support profiles of a patient’s body, in particular diseased skeletal joints, bones, and surrounding muscle tissue (e.g., cervical and lumbar spine, shoulders, elbows, hands, hips, knees, feet). | C |
Category – Physical support
A list of Class C Medical Devices under the category of Physical Support is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Neurocontrolled ambulation exoskeleton | Intended to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. | C |
Category – Interventional Radiology
A list of Class C Medical Devices under the category of Interventional Readiology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Bone densitometer | A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. | C |
| 2 | Emission computed tomography system. | An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data | C |
| 3 | Fluorescent scanner | A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. | C |
| 4 | Nuclear tomography system | A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. | C |
| 5 | Radionuclide rebreathing system | A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). | C |
| 6 | Angiographic x-ray system | An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. | C |
| 7 | Diagnostic x-ray beam-limiting device | A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam | C |
| 8 | Cine or spot fluorographic x-ray camera | A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier | C |
| 9 | Electrostatic x-ray imaging system | An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. | C |
| 10 | Image-intensified fluoroscopic x-ray system | An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification | C |
| 11 | Non-imageintensified fluoroscopic x-ray system | A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. | C |
| 12 | Spot-film device | A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy | C |
| 13 | Mammographic xray system | A mammographic x-ray system is a device intended to be used to produce radiographs of the breast | C |
| 14 | Full-field digital mammography system | A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast | C |
| 15 | Photofluorographic x-ray system | A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body | C |
| 16 | Radiographic film/cassette changer programmer | A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography. | C |
| 17 | Automatic radiographic film processor | An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes | C |
| 18 | Radiologic table | A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered. | C |
| 19 | Radiological computer-assisted diagnostic software for lesions suspicious of cancer | A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. | C |
| 20 | Medical image analyzer | Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians’ attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis. | C |
| 21 | Radiological computer aided triage and notification software | Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. | C |
| 22 | Full-body MRI system, permanent magnet | A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly. | C |
| 23 | Full-body MRI system, resistive magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). It includes a resistive magnet assembly. | C |
| 24 | Full-body MRI system, superconducting magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly. | C |
| 25 | Foetal Doppler system | A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman’s abdomen. The device aids in determining foetal viability | C |
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Category – Dermatology and Plastic surgery
A list of Class C Medical Devices under the category of Dermatology and Plastic Surgery is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Polymer Ligating Clips | “Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. . Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.” | C |
| 2 | Implantable ligating clip | An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable | C |
| 3 | Laser surgical instrument for use in general and plastic surgery and in dermatology. | A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. | C |
| 4 | Ultraviolet lamp for dermatologic disorders. | An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device’s use with that drug | C |
| 5 | Carbon dioxide laser | A gas laser that is used in surgical procedures. It utilizes carbon dioxide as the substrate. It is widely used in several clinical fields (e.g., gynecology, neuroscience, dermatology). | C |
| 6 | Copper vapour laser | A gas laser used in surgical procedures, etc. It utilizes copper vapor as the substrate. It is used in dermatology, etc. for treatment of cutaneous vascular lesions (e.g., port-wine stains, telangiectasia). | C |
| 7 | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. | C |
| 8 | Gastroscope, General & Plastic Surgery | A gastroscope is a flexible tube that has a small light and a video camera attached to the end of it. The tube can be used to take tissue samples by inserting instruments such as small pincers | C |
| 9 | General electrosurgical unit | A device accompanied by accessories that cuts/coagulates tissues with a high-frequency current or with the electricity/heat of the heating element. The device is used by a physician to confirm that an incision or coagulation is made as intended, macroscopically or microscopically | C |
| 10 | Implantable staple | An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable | C |
| 11 | Laparoscope, General & Plastic Surgery | “These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired | C |
Category – Pediatrics and Neonatology
A list of Class C Medical Devices under the category of Pediatrics and Neonatology is given here:-
| S.No | Medical Device Registration | Intended Use | INDIA |
|---|---|---|---|
| 1 | Antimicrobial endotracheal tube, paediatric | A sterile hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated, and which is coated with an antimicrobial agent [e.g., silver (Ag)] to help prevent infection. It may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. | C |
| 2 | Breathing circuit gas-flow sensor, reusable | A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device | C |
| 3 | Breathing circuit gas-flow sensor, single-use | A sterile device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded | C |
| 4 | Cerebral oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2. | C |
| 5 | Craniofacial bone screw, nonbioabsorbable, sterile | A small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures | C |
| 6 | Cuff-suction endotracheal tube | A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device. | C |
| 7 | Enteral feeding kit, adult/paediatric, sterile | A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a long term use device | C |
| 8 | Flexible bone nail, non-sterile | A non-sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures, and some metaphyseal fractures of paediatrics and small-statured/normal adults, to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is intended to splint the cortices and maintain elastic energy to continually brace against rotational/angular forces of the muscles. This is a single-use device intended to be sterilized prior to use. | C |
| 9 | Flexible bone nail, sterile | A sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures and some metaphyseal fractures of paediatrics and small-statured/normal adults to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is intended to splint the cortices and maintain elastic energy to continually brace against rotational/angular forces of the muscles. This is a single-use device. | C |
| 10 | Funnel chest remodelling bar | A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage; devices associated with implantation may be included. This is a single-patient device intended to be sterilized prior to use. | C |
| 11 | Growth-correction orthopaedic fixation plate kit | A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb | C |
| 12 | Infant apnoea monitor | A mains electricity (AC-powered) 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). This will alert the infant’s parent(s), child-minder or hospital staff when such life-threatening episodes occur. This device is usually connected to some form of movement sensing device, e.g., small pads placed directly under the infant or belts with sensors around the chest. It can be designed for use in the hospital/institution, or for home-use | C |
| 13 | Infant incubator control unit | An electronic unit that is used to monitor and regulate the important temperature and environmental features of an infant incubator. It will be connected to the mains electricity (AC-powered) when the incubator is stationary, but will be powered by a battery pack if the incubator is in transport. This device is usually interchangeable with other incubators of the same type. | C |
| 14 | Infant warmer | A mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department. | C |
| 15 | Infant/regional-body warmer | A mains electricity (AC-powered) device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed heat to a newborn/infant patient requiring a supplemental regulated thermal environment, or to provide heat to the limbs of a more mature person, typically an adult, who has been severely burned or who is undergoing a procedure. This is a stationary device that is generally operated at a single site. | C |
| 16 | Internal defibrillator electrode, paediatric | An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a pre-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually consists of a cable set with small-diameter, spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that are held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is typically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device. | C |
| 17 | Lacrimal intubation set | A collection of sterile devices designed to prevent/treat obstruction of and drain tears from the lacrimal ducts. It typically consists of a cannula for insertion into the lacrimal ducts, a tube (e.g., silicone) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing), and a probe to remove ductal obstructions. It can be used for adult and paediatric patients, particularly to treat canalicular pathologies (stenosis, obstruction, wounds, imperforation of the lacrimo-nasal canal in the infant), for prevention of viral and post-chemotherapy stenoses, or for dacryocystorhinostomy (DCR). This is a single-use device. | C |
| 18 | Multifunction cardiac electrode, paediatric | A non-sterile electrical conductor designed to be applied to a paediatric patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device. | C |
| 19 | Neonatal CPAP unit | A mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) of a neonatal/infant patient via an attached nasal cannula or mask, using continuous positive airway pressure (CPAP) during spontaneous respiration. It is an electronic unit with controls, and may be used with compressed medical gas cylinders [e.g., air, oxygen (O2)] or include an O2 concentrator compartment; additional features (e.g., adjustable flow rates and O2 concentration, humidification) may be provided. It is primarily intended for use in a healthcare facility, especially in intensive and critical care settings. | C |
| 20 | Neonatal intensive-care ventilator | A mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls. | C |
| 21 | Neonatal physiologic monitoring system | A device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG), respiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation. The system typically includes sensors with appropriate size and design for infant use. | C |
| 22 | Neonatal/paediatric heart rate monitoring application software | An application software program intended to be installed in an off-the-shelf computer to acquire, record, measure and analyse an electrocardiogram (ECG) signal or heart rate data from a physiological monitor. It typically detects variations in heart rate [e.g., decelerations, reduced baseline heart rate variability (HRV)] in real-time, and is typically used in the neonatal or paediatric intensive care unit (ICU). This device is typically identified by a proprietary name and “version” or “upgrade” number | C |
| 23 | Neonatal/paediatric heart rate monitoring hardware | A mains electricity (AC-powered) device designed to be connected between a physiological monitor and an off-the-shelf computer, containing dedicated application software, and intended to function as a data acquisition node for real-time sampling of neonatal/paediatric patient electrocardiogram (ECG) waveforms for communication to the software for analysis of variations in heart rate. It typically consists of a microprocessor, random access memory (RAM), and analogue-to-digital sampling card, and is typically used in the neonatal or paediatric intensive care unit (ICU) | C |
| 24 | Nitric oxide delivery unit, systembased | A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility | C |
| 25 | Open-surgery manual linear cutting stapler, reprocessed | A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. It operates by a manual mechanism whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a singleuse loading unit (SULU) which may be included. This is a previously used single-use device that has been processed for an additional single-use patient application. | C |
| 26 | Open-surgery manual linear cutting stapler, reusable | A hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a reusable device intended to be sterilized prior to use | C |
| 27 | Open-surgery manual linear cutting stapler, single-use | A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device. | C |
| 28 | Open-surgery manual linear stapler, reusable | A hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a reusable device intended to be sterilized prior to use. | C |
| 29 | Open-surgery manual linear stapler, single-use | A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a singleuse loading unit (SULU) which may be included. This is a single-use device. | C |
| 30 | Paediatric cardiopulmonary bypass cannula | A sterile tube intended to be used during open heart surgery on a paediatric patient (e.g., neonatal, infant) to access the arterial or venous vasculature surrounding the heart (i.e., intended for both venous and arterial access), to serve as a channel intended to be connected to an extracorporeal circuit for the transport of blood to or from a cardiopulmonary bypass system (heart-lung machine) circuit where the blood is pumped and oxygenated. It is typically a reinforced polymer tube which may include accessories/devices dedicated to introduction/function (e.g., introducer/connector). This is a single-use device. | C |
| 31 | Mobile steam washer/disinfector | A mobile, mains electricity (AC-powered) unit designed for the cleaning and high-level disinfection of a range of medical devices (e.g., operating tables, operating lights, neonatal incubators, medical beds, chirurgical instruments) using steam. It includes an electronically controlled boiler unit, for steam generation; hosing, for transfer of the steam; and a hand-held steam application device, typically including accessories (e.g., brush, nozzle, mop), in order to effectively direct steam onto the medical device being disinfected | C |
| 32 | Respiratory gas heating wire, infant | A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gases during ventilation of an infant/neonate. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of a neonatal/paediatric breathing circuit tube. This is a reusable device | C |
| 33 | Stationary pneumatic highfrequency ventilator respiration monitor | A mains electricity (AC-powered) device intended to continuously measure and display respiratory variables associated with the operation of a stationary pneumatic high-frequency ventilator. Measurements include proximal airway pressure, high-frequency percussive rates, mean airway pressures and inspiratory and expiratory times. It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits, and connectors for attachment to the ventilator. It may be used for neonatal, paediatric, and adult patients | C |
| 34 | Syringe pump | A mains electricity (AC-powered) device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries that allow the device to operate for a short period of time when no line power is available (e.g., during transport or a power outage) | C |
| 35 | Transcutaneous intracranial pressure sensor | A non-sterile electronic device exclusively intended for noninvasive measurement of intracranial pressure in a neonatal patient. Sometimes referred to as a fontanometer, it typically consists of a sensor, designed to be topically applied to the fontanel, and a cable, intended to be connected to an appropriate monitor to allow readings to be displayed and/or recorded. It may include a distal balloon to allow pressure baselines to be set. This is a reusable device. | C |
| 36 | Cardiac septostomy catheter, balloon | A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a singleuse device | C |
| 37 | Cardiac septostomy catheter, blade | A flexible tube with a collapsible blade at the distal end that, once in situ, can be raised to an acute angle by the surgeon operating an actuation lever at the proximal end for a blade atrial septostomy (BAS) procedure. It is used to enlarge the interatrial opening in cases of mitral atresia (a septal defect found in the hearts of infants) or unsuccessful or insufficient balloon atrial septostomy. This procedure allows interatrial blood mixing in infants with congenital cardiac malformations. It is typically made of plastic and highgrade stainless steel materials. This is a single-use device. | C |
| 38 | Conventional infant incubator | A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward | C |
| 39 | Home BPAP unit | A portable mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA), and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit, which may include a built-in humidifier, intended to be used with a separate nose/mouth mask. The device is intended for use in the home but may also be used in healthcare facilities. | C |
| 40 | Oxygen breath analyser | A mains electricity (AC-powered) laboratory instrument designed for intermittent/periodic measurements of oxygen (O2) content in a breath and/or respiratory gas specimen. It usually requires manual aspiration of a quantity of gas into a sampling chamber and may operate according to one of several basic principles (e.g., paramagnetism, polarography). The device is used in pulmonary function tests and for measurements in critically ill patients, such as infants in incubators and patients breathing air with supplemental oxygen. | C |
| 41 | Respiratory apnoea monitoring system | An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (ACpowered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient’s breathing condition. | C |
| 42 | 2 Skin transilluminator, batterypowered | A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner. | C |
| 43 | Skin transilluminator, line-powered | A hand-held, mains electricity (AC-powered) device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. It can use varying forms of light depending upon the specific application. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner. | C |
| 44 | Transport infant incubator | An electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack. | C |
Category – Oncology
A list of Class C Medical Devices under the category of Oncology is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | FerriScan R2-MRI Analysis System | The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of nontransfusiondependent thalassemia patients receiving therapy with deferasirox | C |
| 2 | Activated-oxygen generator | Activated Oxygen (Ozone) Activated oxygen, also known as Ozone (O3), is a safe disinfecting agent that SoClean uses to get rid of CPAP bacteria, mold or viruses inside your CPAP equipment | C |
| 3 | Alternating electric field antimitotic cancer treatment system generator | Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis. | C |
| 4 | Alternating electric field antimitotic cancer treatment system transducer array | Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis. | C |
| 5 | Brachytherapy needle | A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy) | C |
| 6 | Breast 3-D infrared imaging/vascular analysis system | An assembly of mains electricity (AC-powered) devices intended for threedimensional (3-D) breast imaging and breast vascular analysis, typically used with mammography screening to perform a breast cancer risk examination. | C |
| 7 | Cancer risk assessment interpretive software | An interpretive software program intended to be used in the assessment of risk for developing cancer (e.g., breast, ovarian, prostate, lung, liver, gastric, pancreatic, colorectal) | C |
| 8 | Cryosurgical set | A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions | C |
| 9 | Electro cancer therapy system | An assembly of devices designed for the treatment of tumours and the destruction of their cancerous cells using low-voltage direct current of small intensity delivered via electrodes placed across the effected body area. | C |
| 10 | Electronic clinical breast examination system | A portable assembly of devices designed to electronically measure, map, document and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE) | C |
| 11 | Endocervical aspirator | A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction | C |
| 12 | Balloon kyphoplasty kit | A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. | C |
| 13 | Accelerator system chair | A seat, typically with legs, that is a component of a therapeutic accelerator system, and used to support and position a seated patient during radiation therapy treatments involving the use of either a medical linear accelerator or non-linear accelerator. | |
| 14 | Accelerator system operator console | A device that is a component of a linear or a non-linear accelerator system that functions as the primary control panel typically for a betatron or cyclotron system. Depending on the configuration, it can include hardware and software that allows for image and/or data display, related processing, analysis functions, data archiving and retrieval. | C |
| 15 | Accelerator system quality assurance device | An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes | C |
| 16 | Anorectal brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the rectum and/or anus. | C |
| 17 | Anorectal brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus. | C |
| 18 | Bile duct brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bile duct. It is an individual device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bile duct | C |
| 19 | Bile duct brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bile duct | C |
| 20 | Bladder brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bladder. | C |
| 21 | Blood photochemical treatment agent | A sterile photochemical agent (psoralen) intended to be used in conjunction with ultraviolet A (UVA) irradiation to eliminate nucleated cells from blood or blood components (e.g., plasma, leukocyte-enriched blood fraction). | C |
| 22 | Brachytherapy source spacer | A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. | C |
| 23 | Brachytherapy system remote afterloading source safe | A component of a remote afterloading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use. | C |
| 24 | Brachytherapy system remoteafterloading operator console | A mains electricity (AC-powered) component of a remote-afterloading brachytherapy system intended to function as the primary control panel for the remote afterloader. It typically includes hardware and software that allows for information display and/or transfer, data processing, analysis, and information archiving functions; it may also be intended to interface with other devices (e.g., radiation therapy treatment planning computer) as part of a picture archiving and communication system (PACS). | C |
| 25 | Breast brachytherapy system applicator, remote-afterloading | A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computercontrolled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device. | C |
| 26 | Breast ultrasound imaging system | An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. | C |
| 27 | Bronchial brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed for temporary use in bronchial radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., endoscopically guided placement, or diagnostic imaging system guided positioning and placement, and removal of single or multiple radioactive sources at the treatment site(s). | C |
| 28 | Bronchial brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in bronchial radiation therapy treatments. | C |
| 29 | Cervical cone knife | A surgical, manually-operated, instrument that is inserted into the vagina and designed for excising a sample of abnormal tissue, e.g., indicated by the presence of precancerous changes, from the cervix. | C |
| 30 | Cervical/intrauterine brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This device includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | C |
| 31 | Class-II biological safety cabinet | A furniture-like device designed as a partial or total enclosure to provide a class II biosafety level (BSL) to the operator, the product, and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens) | C |
| 32 | Electroporation therapy system | A mobile assembly of devices designed to apply electrical impulses to the tissue to enable electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)] and genetic materials [electrogenetherapy (EGT)], to reach the cytoplasm | C |
| 33 | Electroporation therapy system endoscopic applicator | A sterile, patient-contact component of an electroporation therapy system intended to fit onto the distal tip of an endoscope and connect to an electroporation therapy system generator to deliver electrical impulses to tissues during endoscopy as part of electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)], to reach the cytoplasm. | C |
| 34 | Fixed-aperture therapeutic x-ray system collimator | A non-automated, x-ray beam-limiting device that is a component of a therapeutic x-ray system and whose opening size/length/shutter assembly is fixed. It is used in radiation therapy applications to limit the effects of scattered radiation and to protect the patient by limiting or eliminating exposure to nontarget body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system. | C |
| 35 | Flexible fibreoptic mediastinoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device. | C |
| 36 | General-purpose infusion pump, mechanical, single-use | A portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication (e.g., for antibiotic therapy, chemotherapy, analgesia). It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a nonsterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient in and outside of healthcare settings. This is a single-use device. | C |
| 37 | 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. Anatomical images are typically transmitted to the user by the device through a fibreoptic bundle or a video system and an ultrasound probe. The probe may be integral, or a separate device inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to examine the lining of the colon, altered bowel habits, colonic cancer, polyps, diverticular disease, and unexplained anaemia. This is a reusable device | C |
| 38 | General-purpose infusion pump, mechanical, reusable | A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may be used for patient-controlled analgesia (PCA), and may include mechanical indicators for flow and fluid level status. This is a reusable device. | C |
| 39 | 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]. 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 single-use device. | C |
Category – Radiotherapy
A list of Class C Medical Devices under the category of Radiotherapy is given here:-
| S.No | Medica Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Medical chargedparticle radiation therapy system | A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. | C |
| 2 | Absorbable perirectal spacer | An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum | C |
| 3 | Applicator for bile duct manual brachytherapy | A manual brachytherapy applicator specifically designed for bile duct radiation therapy. An applicator designed to have a configuration that facilitates manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therap | C |
| 4 | Applicator for bladder manual brachytherapy | A manual brachytherapy applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bladder. | C |
| 5 | Applicator for bladder remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for bladder radiation therapy. It is designed to be temporarily implanted in the bladder. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. | C |
| 6 | Applicator for brachytherapy bile duct remote afterloading | A remote controlled brachytherapy applicator specifically designed for bile duct radiation therapy. It is designed to be temporarily implanted in the bile duct. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. | C |
| 7 | Applicator for brachytherapy Cervical/endometrial remote afterloading | A remote controlled brachytherapy applicator specifically designed for uterine cervical or intrauterine radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the uterine cervix and endometrium | C |
| 8 | Applicator for brachytherapy noncentral circulatory general-purpose manual | A general-purpose brachytherapy applicator used to facilitate radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy, and placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the non-central circulatory system. | C |
| 9 | Applicator for brachytherapy noncentral circulatory general-purpose remote afterloading | A general-purpose remote controlled brachytherapy applicator used to facilitate radiotherapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the non-central circulatory system. | C |
| 10 | Applicator for bronchial manual brachytherapy applicator | A manual brachytherapy applicator specifically designed for temporarily use in bronchial radiation therapy. A single or module applicator designed to facilitate manual placement (placement using an endoscope or positioning, placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. It may be designed to be standard in configuration or to handle specific radiation sources. | C |
| 11 | Applicator for bronchial remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for bronchial radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the bronchus. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors. | C |
| 12 | Applicator for esophagus manual brachytherapy | A manual brachytherapy applicator specifically designed for esophagus radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the esophagus. It may be designed to be standard in configuration or to handle specific radiation sources. | C |
| 13 | Applicator for esophagus remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for esophagus radiation therapy. It is designed to be temporarily implanted in the esophagus. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors. | C |
| 14 | Applicator for eye manual brachytherapy | A template with a groove on the one side. The groove shows the position of the brachytherapy source that is manually, temporarily delivered to the eye surface. The other side is shielded. | C |
| 15 | Applicator for manual cervical/endometrial brachytherapy | A manual brachytherapy applicator specifically designed for uterine cervix or intrauterine radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, placement with an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. | C |
| 16 | Applicator for manual rectal/anal brachytherapy | A manual brachytherapy applicator specifically designed for rectal and/or anal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the rectum and/or anus. | C |
| 17 | Applicator for nasopharynx manual brachytherapy | A manual brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the nasopharynx. | C |
| 18 | Applicator for nasopharynx remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the nasopharynx. | C |
| 19 | Applicator for neck manual brachytherapy | A manual brachytherapy applicator specifically designed for neck radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the neck tissues. | C |
| 20 | Applicator for neck remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for neck radiation therapy. It is designed to be temporarily implanted in the neck tissues. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. | C |
| 21 | Applicator for pancreas manual brachytherapy | A manual brachytherapy applicator specifically designed for pancreatic radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, endoscopic placement, or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the pancreas. It may be designed to be standard in configuration or to handle specific radiation sources. | C |
| 22 | Applicator for pancreas remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for pancreatic radiation therapy. It is designed to be temporarily implanted in the pancreas. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. | C |
| 23 | Applicator for prostate manual brachytherapy | A manual brachytherapy applicator specifically designed for prostate radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement or removal with a trigger loading device, an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the prostate gland. It may be designed to be standard in configuration or to handle specific radiation sources. | C |
| 24 | Applicator for prostate remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for prostate radiation therapy. It is designed to be temporarily implanted in the prostate gland. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. | C |
| 25 | Applicator for rectal/anal remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for rectal or anal radiation therapy. It Is designed to be temporarily implanted in the rectum or anus. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources | C |
| 26 | Applicator for tongue manual brachytherapy | A manual brachytherapy applicator specifically designed for lingual radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the tongue and the surrounding tissues. It may be designed to be standard in configuration or to handle specific radiation sources. | C |
| 27 | Applicator for tongue remote afterloading brachytherapy | A remote controlled brachytherapy applicator specifically designed for tongue or oral cavity radiation therapy. It is designed to be temporarily implanted in the tongue or the surrounding tissues. It serves as a guide for computercontrolled temporary placement and removal of a single or multiple therapeutic radiation sources. | C |
| 28 | Applicator for vaginal manual brachytherapy | A manual brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites | C |
| 29 | Applicator for vaginal remote afterloading brachytherapy | A remote-controlled brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of single or multiple therapeutic radiation sources in the vagina. | C |
| 30 | Bile duct brachytherapy system applicator, remote afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bile duct. It is designed for temporary insertion into the bile duct and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. | C |
| 31 | Bladder brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder. | C |
| 32 | Brachytherapy needle | A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). | CC |
| 33 | Brachytherapy radionuclide phantom, anthropomorphic | A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs | C |
| 34 | Brachytherapy system remote afterloading source safe | A component of a remote afterloading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use. | C |
| 35 | Brachytherapy system remote afterloading source transfer tube | The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient. | C |
| 36 | Brain brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the brain. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the brain. | C |
| 37 | Breast discography cannula | A thin, sterile, semi-rigid, or rigid metal tube that is inserted into the nipple of the female breast to inject a contrast medium into the lactiferous ducts to enhance their visualization during a radiographic procedure. | C |
| 38 | Conformal Brachytherapy Source | The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. | C |
| 39 | High-frequency hyperthermia system | A system used to generate high-temperatures and to control the provision of heat to the body in the treatment of malignant and benign tumors, or other diseases. | C |
| 40 | Medical neutron radiation therapy system | A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy | C |
| 41 | Living tissue radiotherapy system | A low energy X-ray therapy system designed to treat adjacent tumor lesions with high dose X-rays by placing soft X-ray beams from 5 to 50 kV inside the tumor tissue. T It is used in both intraoperative radiation and stereotactic localized radiation therapy. | C |
| 42 | MOSFET radiation therapy dosimetry system | An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research | C |
| 43 | Non-central circulatory manual brachytherapy therapeutic radionuclide system | A device that places a radiation source manually or automatically at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy. | CC |
| 44 | Non-central circulatory permanent implant manual brachytherapy therapeutic radionuclide source | A non-central cardiovascular device which is histocompactible and containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be permanently implanted in the body for radiation therapy requiring treatment or symptomatic treatment. | C |
| 45 | Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide source | A device for the non-central circulatory system used as radiation source to deliver a high or low dose rate with an after-loading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. | C |
| 46 | Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide system | A device that places a radiation source temporarily at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation source transporter. | C |
| 47 | Non-central circulatory temporary placement manual brachytherapy therapeutic radionuclide source | A non-central cardiovascular device containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be temporarily implanted in the body and to be removed after a prescribed duration of treatment. Used in brachytherapy, the device is placed and removed manually or under endoscopic observation. | C |
| 48 | Nuclear medicine positron emission tomography system | A positron emission tomography (PET) system specifically designed to detect, record, quantify, and analyze the pattern of 511-keV photon emissions generated by annihilation from the decay of positron-emitting radiopharmaceuticals. | C |
| 49 | Patient positioning device for breast diagnostic imaging and radiotherapy | A device that is specifically designed to properly position and fix a female patient’s breasts and chest for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy | C |
| 50 | Patient positioning device for extremity diagnostic imaging and radiotherapy | A device that is specifically designed to properly position and fix a patient’s arms and legs for image diagnosis, imageguided surgery, interventional therapy, or radiotherapy | C |
| 51 | Post Breast Biopsy Hemostatic Breast Compression Device | A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. | C |
| 52 | Powered radiation therapy patient support assembly | A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy | C |
| 53 | Radiation therapy beam-shaping block | A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source | C |
| 54 | Radiation therapy simulation system | A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. | C |
| 55 | Radio-frequency ablation system | A system that heats and cauterizes malignant or benign tumors, etc. with radio wave energy. | C |
| 56 | Radio-frequency lesion generator system with probe | A device that administers a high-frequency electric current (radio frequency) to the internal nerves in order to increase temperature in a controlled way to create a therapeutic lesion. | C |
| 57 | Radionuclide brachytherapy source | A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy | C |
| 58 | Radionuclide radiation therapy system. | A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient’s body. | C |
| 59 | Radionuclide sourcefor remote irradiationtherapy | Radiation sources generated in a reactor and used as in a remote afterloading system designed to deliver a therapeutic radiation beam to a target anatomical area. The radiation sources incorporated as a component of the remote afterloading system are generally sealed. | C |
| 60 | Radionuclide system contour detector for remote irradiation therapy | Intended to precisely determine the outline of the area of the body to be irradiated. Usually, the information obtained from this device is entered into a radiotherapy planning system and utilized for the radiotherapy plan | C |
| 61 | Real-time position management respiratory gating system, optical | An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. | C |
| 62 | Rectal balloon for prostate immobilization | A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. | C |
| 63 | Remote controlled radionuclide applicator system | A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. | C |
| 64 | Stereotactic radiotherapy accelerator system | A stereotactic radiation therapy system for treatment based on a linear accelerator (or microtron). The device may be used to inactivate lymphocytes. | C |
| 65 | X-ray CT system for radiotherapy planning | A X-ray CT system that has a special configuration, containing hardware, software, etc. used in radiotherapy planning. It is used to determine the size and positioning of the therapeutic radiation field based on a series of treatment parameters to be generated. | C |
| 66 | X-ray radiation therapy system | An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy | C |
| 67 | 1 X-ray/CT combined linear accelerator system | A combined system of a linear accelerator system and an Xray CT system for radiotherapy planning. | C |
| 68 | X-ray/CT combined particle radiotherapy equipment | A combined system of particle radiotherapy equipment and an X-ray CT system for radiotherapy planning. | C |
Category – Nephrology and Renal Care
A list of Class C Medical Devices under the category of Nephrology and Renal Care is given here:-
| S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Automated peritoneal dialysis system | An active medical devices intended to perform peritoneal dialysis | C |
| 2 | Dialysis apheresis unit, Therapeutic | Intended to filtrates the blood and separates the plasma, and extracts specific substances in the plasma (e.g., LDLcholesterol). Then, the plasma is passed through the filtration column in the device and the specific substances that are combined with various substrates are extracted. | C |
| 3 | Disposable Hemoperfusion Cartridge | Inteded in hemoperfusion machine to thoroughly remove the endogenous and exogenous materials such as residual drugs, toxins and metabolic substances in patients by means of adsorption of synthetic resin and extracorporeal blood circulation | C |
| 4 | Electrical conductivity measuring instrument for dialysis fluid | Intended to determine the concentration of dialysis fluid supplied to a dialyzer based on the measurement of electrical conductivity of dialysis fluid (usually, it is electrically measured. ). | C |
| 5 | Haemodialyzer reprocessing system | Intended to clean (incl. rinsing, cleaning, testing and record keeping of process) and disinfect haemodialysis dialyzers after each use so that they can be reused. | C |
| 6 | Haemofilters | A filter used in the process of haemofiltration, to allow for the removal of toxins and/or the replacement of electrolytes. | C |
| 7 | Hemodiafiltration system | A device used for blood purification with a hemodiafilter. | C |
| 8 | Hollow-fibre haemodialysis dialyser | Hollow fiber filter intended to remove impurities/fluid from the blood of a patient via haemodialysis machine. | C |
| 9 | Kidney donor-organ preservation/transport system | A dedicated system designed to support and maintain a donated kidney organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. | C |
| 10 | Kidney stone filter | A filter intended to be placed in the urinary duct to prevent a renal stone from moving from the kidney into the bladder. | C |
| 11 | Multi-patient dialysis fluid delivery system | Intended to prepares dialysis fluid for hemodialysis | C |
| 12 | Peritoneal dialysis catheter adaptor | Intended to connect (devices of different makers and makes devices compatible with each other) a catheter for peritoneal lavage to an external device that manages dialysates. | C |
| 13 | Peritoneal dialysis dialysate warmer | Intended to heat the dialysate to within on degree, of kidney patient who is on continuous ambulatory peritoneal dialysis (CAPD), body temperature prior to infusion. | C |
| 14 | Reverse Osmosis Unit (for dialysis) | Intended to be used with haemodialysis to produce water through reverse osmosis with quality suitable for use with hemodialysis equipment. | C |
| 15 | Haemodialysis concentrate | Intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels while haemodilysis is performed. | C |
| 16 | Haemodialysis conductivity standard solution | Intended to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. | C |
| 17 | Haemodialysis system air/foam detector | Intended to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. | C |
| 18 | Haemodialysis system bicarbonate mixer | Intended to mixes two concentrates, A and B, plus water, to the dialysis solution (dialysate) and monitors the mixture. | C |
| 19 | Haemodialysis system central monitor | Device intended to connect with multiple haemodialysis systems in order to aid monitoring several dialysis treatments simultaneously. | C |
| 20 | Peritoneal dialysis system dialysate filter | A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity. | C |
| 21 | Sodium carbonate haemodialysis system cleaning cartridge | Intended to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program. | C |
Category – Software
A list of Class C Medical Devices under the category of Software is given here:-
S.No | Medical Device Name | Intended Use | INDIA |
|---|---|---|---|
| 1 | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors. The device is software with a graphical user interface. | C |
| 2 | Coronary Vascular Physiologic Simulation Software | A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease by performing offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature. | C |
| 3 | Angiographic Coronary Vascular Physiologic Simulation Software | An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease | C |
| 4 | Software For Visualization Of Vascular Anatomy And Intravascular Devices | Visualization and measurement of blood vessels and intravascular devices for preoperational planning | C |
| 5 | Orthodontic Software | The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions | C |
| 6 | Dental Abutment Design Software For Dental Laboratory | The software device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. | C |
| 7 | Neuropsychiatric Interpretative Electroencephalogr aph Assessment Aid | Intended as an aid to provide an interpretation of the patient’s neuropsychiatric condition. | C |
| 8 | Normalizing Quantitative Electroencephalogr aph Software | Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified clinical user. | C |
| 9 | Index-Generating Electroencephalogr aph Software | Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified clinical user | C |
| 10 | Source LocalizationSoftware ForElectroencephalograph OrMagnetoencephalograph | Correlation of electrical activity of the brain using various neuroimaging modalities for sourcelocalization | C |
| 11 | Automatic Event Detection Software For Polysomnograph With Electroencephalogr aph | Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified clinical user | C |
| 12 | Automatic Event Detection Software For Full-Montage Electroencephalogr aph | Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified clinical user | C |
| 13 | Computerized Cognitive Assessment Aid For Concussion | For use as an assessment aid in the management of concussion | C |
| 14 | Computerized Behavioral Therapy Device For Psychiatric Disorders | The device is intended to provide cognitive behavioral therapy to treat substance use disorder. The device is a software-based mobile app downloaded onto a smartphone. | C |
| 15 | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. | C |
| 16 | Device, Fertility Diagnostic, Contraceptive, Software Application | Designed to monitor and provide fertility information to prevent pregnancy (contraception). | C |
| 17 | Diabetic Retinopathy Detection Device | A retinal diagnostic software device is a software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. | C |
| 18 | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Assist clinical users in characterizing lesions identified on acquired medical images | C |
| 19 | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). | C |
| 20 | Burn Resuscitation Decision Support Software | The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn. | C |
| 21 | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types | This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. | C |
| 22 | Software for peritoneal dialysis treatment | A software that performs prescription simulation of peritoneal dialysis based on the results obtained from a peritoneal function test (PFT), a peritoneal equilibration test (PET) and a body composition analyzer. It supports preparation of a dialysis treatment plan. | C |
| 23 | Software for radiation plannin | A software that calculates and displays the area to be treated with radiation and the internal dose distribution based on the results obtained with CT systems etc. , and supports the radiotherapy planning. | C |
| 24 | Software for radiotherapy QAQC planning | A software that verifies the validity of the radiotherapy plan by recalculation of the dose and the MU value calculated with the radiotherapy planning system software and radiotherapy planning system | C |
| 25 | Software for ophthalmic surgery treatment planning | A software for intended to aid ophthalmic surgical planning based on measurement of the eye prior to the surgery. It simulates surgical results. | C |
| 26 | Software for active implanted device control | A software used to transmit one or more electrical operating characteristics noninvasively to the active base unit and change the characteristics. | C |
| 27 | Information collating software for radiotherapy | A software that has function of collating the information such as irradiation parameter specified by a radiation planning software, and the condition that a radiotherapy equipment irradiates, on the occasion of the irradiation of X-ray in the radiotherapy | C |
| 28 | Software for gene variants analysis (for cancer genome profiling) | A software for gene variants analysis which is designed to perform cancer genome profiling based on information of gene variants obtained from body tissue samples. | C |
| 29 | Supporting software for differential diagnosis with endoscopic imaging | A software, which is designed to process data obtained from an endoscopic image. The resultant data are provided for diagnostic, etc. It has functions to output numeric values and graphs based on quantitative data such as benign/malignant differentiation of lesion candidates, presenting candidates of diagnostic outcomes, and stage of disease progression. | C |
What are the Examples of Class C Medical Devices?
Class – C Medical Devices spread high risk because devices comes under this category can come in contact with bosy for long time period that can produce major risks. Here are some examples of Class – C Medical Devices:-
1 – Radiologic table – A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
2 – Pulse oximeter – A device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2)
What are Class C and D Medical Devices?
Both these Class – C Medical Devices and Class – D medical devices are high in risk and more complex then both these A & B class of medical devices.
What is a Class C Medical Devices in India?
Class C Medical Devices possess high risks compared to Class A and B. Only upper authorities can deal with these processes, like the Central licensing authorities, which is the drug controller general of India. To apply for a medical device certificate, click on it.