Class A medical devices possess the least risk exposure device category. Medical devices that come under Class A are the minimum danger category and it is easy to register, medical device under Class A category. It is primarily known for its features, that it is non-invasive, and meant to be used for a temporary period, this is the reason for its less risk category.

Class A medical devices cover many daily healthcare products for example – examination gloves, manual bandages, and adhesive bandages.

Here you can check category-wise products of Class-A – Medical Devices, mentioned in the table below:-

Category – ANESTHESIOLOGY

A list of Class A Medical Devices under the category of Anesthesiology is given here:-

S.No	MEDICAL DEVICE NAME	INTENDED USE	INDIA
1	Aerosol delivery tubing	A flexible tube used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer, intended for the delivery of aerosolized humidification, typically oxygen enriched.	A
2	Airway device cleaning utensils	A hand-held device intended to be used to clean an in-situ and ex-situ airway device.	A
3	Airway pressure alarm	A device connected to the breathing circuit monitors a patient’s upper airway pressure during assisted mechanical ventilation.	A
4	Airway protection face mask	A flexible, form-shaped device that is placed over the nose and mouth to provide respiratory protection	A
5	Airway tube forceps	A hand-held instrument used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways.	A
6	Anaesthesia catheter Luer connector	It is a device intended to create a mechanical union between an anaesthesia catheter and an external device, via a Luer connection	A
7	Anaesthesia depth simulator	A device intended to simulate the electroencephalography(EEG) signals of an unconscious patient (in a state of anaesthesia) in order to test and calibrate an anaesthesia depth monitor, check patient cable continuity, or train healthcare providers.	A
8	Anaesthesia instrument table	It is intended as a support for anaesthesia instruments used during general anaesthesia surgical procedures.	A
9	Anaesthesia mask stabilizer	A device intended to secure an anaesthesia mask on the face of a patient typically by providing anchorage for thefixation of the mask’s headstrap.	A
10	Anaesthesia system leakage tester	A device intended to test an anaesthesia system for leakage.	A
11	Anaesthesia warmer	A device intended to warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia.	A
12	Anaesthetic gas scavenging terminal unit	A device intended to function as an outlet assembly to which the operator can connect/disconnect an anaesthetic gas scavenging system (AGSS).	A
13	Anesthesia Face Mask	A device designed to be placed over a patient’s nose and/or mouth to administer anaesthetic gases to the upper airway	A
14	Artificial airway stylet	A device intended for insertion within the lumen of an artificial airway tube to stiffen and/or maintain the shape of the tube to facilitate intubation	A
15	Atomizer	A device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe.	A
16	Breathing circuit bag	A device intended to store breathing gas during the respiratory cycle	A
17	Breathing circuit condenser	A device that is used to dry breathing circuit equipment that has been washed in order to prevent bacteria growth and deterioration	A
18	Breathing circuit dryer	A device that is used to dry breathing circuit equipment that has been washed in order to prevent bacteria growth and deterioration	A
19	Breathing mouthpiece	A device intended to be inserted into a patient’s mouth to facilitate access to the respiratory system.	A
20	Bronchial cannula	A tube-shaped surgical instrument that is inserted into the lumen of the bronchus by means of a trocar blade to provide rigidity.	A
21	Bronchoscope	An endoscope with an inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs and take biopsies and sample of secretions.	A
22	Bulk oxygen concentration system	An assembly of devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2,with purity of up to 99.5%, to the hospital medical gas supply system.	A
23	Capnography oxygen mask	A device intended to be placed over the nose and mouth todeliver oxygen (O2) to a patient’s airway and to sample exhaled respiratory gases for monitoring the patient’sventilatory status.	A
24	Capnography sampling adaptor	The device is intended for sampling CO2 and use with monitors enabled with capnography technology.	A
25	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anesthesia and/or ventilation.	A collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient’s lung airways (bronchial lumens).	A
26	In-line arterial blood sampling set	A collection of devices designed to obtain an in-line arterial blood specimen while maintaining a closed system.	A
27	In-line backflow valve	A general-purpose device used in medical tubing or pipelines to prevent the backflow of gases or liquids.	A
28	Intubation laryngoscope	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube before the delivery of inhalation anaesthesia and/or ventilation.	A
29	Intubation teeth protector	A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures.	A
30	Laryngeal airway	A curved tube is used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients.	A
31	Laryngeal airway introducer	Mechanical positive pressure airway secretion-clearing device	A
32	A main component of a medical gas pipeline supply system that monitors the composition of a gas delivered from thesupply system.	A hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease.	A
33	Medical gas flowmeter	A device intended to measure and regulate the flow of a medical gas during various procedures.	A
34	Medical gas flowmeter, Thorpe tube	A device intended to measure and regulate the flow of a medical gas during various procedures	A
35	Medical gas pipeline system	An assembly of devices designed to supply compressed medical gases from a central source to endpoints throughout a medical facility.	A
36	Medical gas pipeline system automaticoutlet analyser	A main component of a medical gas pipeline supply system that monitors the composition of a gas delivered from the supply system.	A
37	Medical gas pipeline system pressure monitor	A component of a medical gas pipeline system designed to continuously monitor and detect changes in the pressure values of the medical gases in the supply pipeline.	A
38	Medical gas terminal unit	A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for a single/mixture of gas to which the operator can connect and disconnect a medical device.	A
39	Nasopharyngeal airway	A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency.	A
40	Nerve-block injection manometer	A noninvasive device intended to be connected between a syringe and a nerve-block needle to indicate injection pressure during administration of local or regional anaesthesia to achieve peripheral nerve blockade	A
41	Non-rebreathing oxygen face mask	A flexible, form-shaped device designed with a valve to control rebreathing and contamination of gas, placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient’s airway for oxygen therapy.	A
42	Nose clip	A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function and/or to stop nosebleeds.	A
43	Oropharyngeal airway	A curved metal or plastic tube is inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow.	A
44	Oxygen administration hood	A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient’s O2 uptake.	A
45	Oxygen saturation/pulse rate simulator	A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.	A
46	Rebreathing oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient’s airway	A
47	Rigid non-bladed video intubation laryngoscope	A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalationanaesthesia and/or ventilation.	A
48	Spirometer/pulmonary function analyser syringe	A device consisting of a barrel (cylinder) with a plunger/piston intended to be used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference.	A
49	Tracheal surgery dilator	A hand-held manual surgical instrument intended to be used during the surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostomy and/or for expanding the margins of a tracheostomy to assist in the insertion of a tracheostomy tube.	A
50	Tracheostomy tube cannula	A hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, there by preventing blockage and infection of the stoma and eliminating the traumatic removal of the tracheostomy tube.	A
51	Tracheotome	A surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy).	A
52	Ultrasonic cough stimulation system	An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency or the very young/elderly, to help clear the lungs of secretions and aspirated materials.	A

Category – Pain Management

S.No	Medical Device Name	Intended Use	INDIA
1	Acupressure calf band	A device designed to be worn around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome.	A
2	Acupressure wristband	A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea.	A
3	Bite relief pad	A thin, plastic, horshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment.	A
4	Ear microsystem needle	An instrument used in auriculotherapy to apply continuous pressure to stimulate meridian points.	A
5	Ice bag	Intended to alleviate pain and/or promote healing in minor injuries of the body or for application around the neck or limbs.	A
6	Ice collar	Intended to alleviate pain and/or promote healing in minor injuries of the neck, throat, and/or head and to alleviate a sore throat.	A
7	Intubation teeth protector	A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures.	A
8	Inversion table	A fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back\muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down), thereby assisting patients in eliminating/alleviate back pain.	A
9	Massage table/couch	A table designed for various kinds of complementary therapy.	A
10	Pain-relief phototherapy skin patch	A skin patch designed to reflect the naturally emitted infrared energy back into the body, with a reduced range of wavelength, intended to provide comfort and localized temporary relief of body aches and pains by phototherapeutic stimulation of strategic points on the skin.	A
11	Pain-relief static magnet	A magnetized metal device designed to be worn on any part of the body (non-dedicated) and intended to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief of body aches and pains.	A
12	Sitz bath	A tub filled with water, that is heated by its heating elements and circulated by its agitators, is intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.	A
13	Sitz bath chair	A device designed to be sat upon by a patient in a powered sitz bath for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.	A
14	Static magnetic bed mattress overlay	A pad made of textile fabrics containing magnetic inserts intended to be placed on top of a bed mattress and contact an occupant’s body to help relieve medical ailments such as pain, muscle tension, and poor blood circulation and to provide comfort by improving overall mobility.	A
15	Static magnetic belt	A device, typically fashioned as a piece of clothing, containing or impregnated with a magnetized metal(s) or a metallic compound(s), designed to be worn around the waist to produce a weak magnetic flux field that emanates from the waist to assist the whole body’s innate healing capability to alleviate body aches and pains.	A
16	Static magnetic bracelet	A device, typically fashioned as a piece of jewellery, containing or impregnated with a magnetized metal(s) or a metallic compound(s), designed to be worn around the wrist to produce a weak magnetic flux field that emanates from the surface of the wrist to assist the whole body’s innate healing capability to alleviate body aches and pains.	A
17	Static magnetic massager	A device designed to be moved over body surfaces that uses static magnets intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains.	A
18	Traction system belt	A harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae.	A

Category – Cardiovascular

A list of Class A Medical Devices under the category of Cardiovascular is given here:-

S.No	Name of Medical Device	Intended Use	INDIA
1	Pacemaker test magnet	A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.	A
2	Pacemaker service tools	Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator.	A

Category – Dental

A list of Class A Medical Devices under the category of Dental is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Dental collar/crown scissors	Scissors are used to cut delicate tissue and remove sutures to perform precision procedures.	A
2	Dental excavator, reusable	It is a device intended to cut, clean out and shape a carious cavity before filling it.	A
3	Dental excavator, single-use	It is a single-use device intended to cut, clean out and shape a carious cavity before filling it.	A
4	Intended to clean plaque from teeth and gum.	It uses electric power to move the brush head, normally in an oscillating pattern.	A
5	Basic manual toothbrush	It is a small bowl used to mix and hold dental materials.These dishes can be disposable or reusable	A
6	Dappen dish, reusable	It is a small bowl used to mix and hold dental materials. These dishes can be disposable or reusable	A
7	Dappen dish, single-use	A small, shallow concave vessel used to knead and hold dental materials.	A
8	Dental examination kit	Intended as a kit for dental examination.	A
9	Dental material mixing surface, reusable	A dental instrument slab or tray is used as a surface to mix dental materials.	A
10	Dental material mixing surface, single-use	It has a pad or tray used to knead or mix dental material (impression material, cement, etc).	A
11	Dental spatula, reusable	A dental instrument used to mix dental materials. Some are equipped with an injection function.	A
12	Dental spatula,single-use	A spatula-shaped device used to knead or mix dental material (impression material, cement, etc).	A
13	Wax dentalimpression material	It is used to take an oral impression. Made of wax, some materials are mixed with resin having a low melting point.	A
14	Dental impression material kit, reusable	Devices and materials used to take the impression.	A
15	Dental impression material kit, single use	A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s); This is a single-use device	A
16	Dental impression material mixer	An electric device is used to mix impression materials immediately before use at the chair side.	A
17	Dental impression material syringe	This dental injection syringe is used to inject the impression material onto the impression tray.	A
18	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The material is used in cases in which a preformed impression tray is not suitable.	A
19	Dental impression tray, reusable	An impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient’s teeth to reproduce the structure of a patient’s teeth.	A
20	Dental polishingbrush	A rotary dental brush intended for cleaning and polishing by a dental hygienist or a dentist.	A
21	Dental suction system cannula, reusable	A tubal dental device is to be connected to a non-active aspiration device (usually, a dentistry-dedicated device). Used to eliminate water and cutting debris that has accumulated in the oral cavity. This device is reusable after sterilization	A
22	Dental suction system cannula, single-use	A tubal dental device is to be connected to a non-active aspiration device (usually, a dentistry-dedicated device). Used to eliminate water and cutting debris that has accumulated in the oral cavity.	A
23	Dental suction system fluid separation unit	A separator is used in the oral cavity. Used for the separation of fluids (saliva, blood) from gases to prevent liquids from entering the suction pump (i.e., dry suction).	A
24	Plaster dental impression material	This material is primarily made of calcium sulphate hemihydrate and is used to take an oral impression.	A
25	Assistive manual toothbrush, reusable	Used to clean plaque.	A
26	An assistive manual toothbrush, single-use	Used to clean teeth and gum.	A
27	Bar dental precision attachment	It connects removable partial dentures to fixed bridgework under a male/female locking mechanism.	A
28	Basic electric toothbrush, battery powered	A rotary dental brush is used for cleaning teeth and gum by a person or a dental hygienist.	A
29	Dental cotton roll	It is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure.	A
30	Dental impression tray, single-use	The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.	A
31	Dental articulation paper forceps	A hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient’s oral cavity.	A
32	Dental dressing forceps, reusable	A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient’s oral cavity.	A
33	Dental dressing forceps, single-use	A sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient’s oral cavity.	A
34	Rubber dam clamp forceps	A hand-held dental instrument is used for the insertion and removal of rubber dam clamps.	A
35	Tooth extraction forceps	A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth	A
36	Dental amalgam capsule	A small container in which silver (Ag) alloy is intended to be mixed with mercury (Hg) to form dental amalgam.	A
37	Dental amalgam mercury dispenser	A device with a valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form which is to be used to produce amalgam filling material.	A
38	Dental anaesthesiaSyringe, intraligamentary	A hand-held manual dental instrument intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.	A
39	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included.	A
40	Dental anaesthesia syringe, single-use	A sterile, hand-held, manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included).	A
41	Dental anaesthesia syringe/needle	A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle; the needle may be attached or detached.	A

Category – ENT

A list of Class A Medical Devices under the category of ENT is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Adenotome	A surgical instrument intended to dissect the adenoids	A
2	Audiometer testing system	An assembly of electronic reference devices intended to calibrate an audiometer.	A
3	Ear bowl	Constructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable treatments of the ear.	A
4	Ear canal impression tray	Intended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal.	A
5	Ear canal light	Intended to illuminate the ear canal.	A
6	Ear excavator	Designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear.	A
7	Endaural curette	Designed for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim).	A
8	ENT transilluminator	Intended to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination	A
9	Nasal septum straightening forceps	Surgical instrument specifically designed to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures.	A
10	Tonsil knife	Intended for the removal of the tonsils during a surgical intervention	A
11	Tracheal bistoury	Designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea	A
12	Bone particle collector	A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.	A
13	External nasal splint	An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.	A
14	Acoustic chamber for audiometric testing	An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.	A
15	ENT cupped forceps	A forceps with a spoon-(dish) like configuration at the distal end, and is used to treat the ear, nose, and throat (ENT), and remove tissue from the body.	A
16	Tongue depressor	A surgical instrument is used to move the tongue to facilitate the examination of surrounding organs and tissue.	A
17	Tracheal dilator	Intended to dilate the tracheal structure and tracheal passageway.	A
18	Tonsillectomy	A manually operated surgical device is used to dissect the tonsils.	A

Category – Gastroenterology

A list of Class A Medical Devices under the category of Gastroenterology is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Closed-ended intestinal ostomy bag, multiple-piece	A non-sterile plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed].	A
2	Closed-ended intestinal ostomy bag, one-piece	A non-sterile plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed].	A
3	Enema tip, reusable	A non-sterile device made with Hevea natural rubber latex (NRL) intended to be connected to an enema tube to facilitate the delivery of an enema solution into the rectum.	A
4	Enema tube	A non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum.	A
5	Enteral feeding/decompression tube clearing stem	A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency.	A
6	Enteral tube extension, non-sterile	A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration.	A
7	Enteral tube extension, sterile	A sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration.	A
8	Gastrointestinal ostomy tube pocket	A non-sterile, noninvasive pouch designed to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient.	A
9	Gravity enema set	A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine.	A
10	Intestinal ostomy bag anti-adhesion device	A non-sterile, noninvasive device intended to be applied to the inner surface of an intestinal ostomy bag to prevent opposing inner walls of the bag from sticking together (anti-pancaking).	A
11	Intestinal ostomy kit	A collection of non-sterile devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure).	A
12	Nasogastric tube holder, noninvasive, non-sterile	A small, non-sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient.	A
13	Nasogastric tube holder, noninvasive, sterile	A small, sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient.	A
14	Rectal/colonic lavage support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon.	A
15	Rectoscope/proctoscope handle	A manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure.	A

Category – Urology

S.No	Medical Device Name	Intended Use	INDIA
1	Bladder neck spreader	A manual gastroenterology-urology surgical instrument with specially designed moveable blades intended to be used to separate and spread the bladder neck. This is a reusable device.	A
2	Closed-ended wearable urine collection bag, nonsterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage.	A
3	Closed-ended wearable urine collection bag, sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage.	A
4	Diaphragm wearable urinal	A non-sterile urine drainage device designed for men with incontinence consisting of a front piece with scrotal support and a leak-proof, flexible diaphragm through which the penis passes into a closed cone-shaped tube connected to a leg bag into which the urine is collected.	A
5	Draping incontinence liner	A non-sterile padded sheet intended to cover and protect a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person by catching and retaining urine.	A
6	Drip wearable urinal	A non-sterile urine drainage device designed for men to contain a moderate leakage consisting of a front piece with an integrated tubular sheath that fits fully over the penis and into which dribbling urine is collected.	A
7	Female wearable urinal, reusable	A non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag	A
8	Hand-held urinal, female	A portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bedbound) patient for excretory purposes.	A
9	Hand-held urinal, male, reusable	A portable, hand-held container intended to be directly urinated into by a male (typically bed-bound) patient for excretory purposes.	A
10	Home faecal specimen collection kit	A collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology).	A
11	Incontinence device suspender	A device used by a person with a disability to secure a body-worn incontinence device [e.g., a nappy (diaper) or a pad] in a stable and safe position.	A
12	Incontinence pants liner	A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.	A
13	Incontinence pants, reusable	An underwear designed to retain urine leakage in incontinent adults and older children.	A
14	Incontinence penis clamp, reusable	A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder.	A
15	Urethral/suprapubic catheter valve-connector	A small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage).	A
16	Urinary-incontinence vaginal insert, reusable	A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion).	A

Category – General Hospital

A list of Class A Medical Devices under the category of General Hospital is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Intended to be placed under the mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.	Intended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.	A
2	Stand-on patient scale	Intended for medical purposes it is used to weigh a patient who can stand on the scale platform	A
3	Patient scale	A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale by placing a scale under a bed or chair to weigh both the support and the patient.	A
4	Clinical colour change thermometer.	A clinical colour change thermometer is a disposable device used to measure a patient’s oral, rectal, or axillary (armpit) body temperature.	A
5	Apgar timer	The Apgar timer is a device intended to alert a healthcare provider to take the Apgar score of a newborn infant.	A
6	Hydraulic adjustable hospital bed.	Intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed	A
7	Manual adjustable hospital bed.	A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed.	A
8	Nonpowered flotation therapy mattress.	A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores).	A
9	Therapeutic medical binder.	Intended to wrap around a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants	A
10	Burn sheet.	Inteded to wrap around a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants	A
11	Neonatal eye pad.	A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy	A
12	Nipple shield	A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman.	A
13	Lamb feeding nipple.	A lamb-feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities	A
14	Suction snakebite kit.	Intended for removing venom from the wound.	A
15	Therapeutic scrotal support.	Intended for medical purposes to support the scrotum (the sac that contains the testicles)	A
16	Umbilical occlusion device.	An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.	A
17	Cardiopulmonary resuscitation board.	Intended to be placed under a patient to act as a support during cardiopulmonary resuscitation.	A
18	Medical insole.	Intended for medical purposes it is placed inside a shoe to relieve the symptoms of athlete’s foot infection by absorbing moisture.	A
19	Skin pressure protectors.	A skin pressure protector is a device intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient’s developing decubitus ulcers (bedsores)	A
20	Body waste receptacle	A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient	A
21	Hand-carried stretcher.	A hand-carried stretcher is a device intended to carry a patient as an assistance for injury or disability.	A
22	Liquid crystal vein locator.	Intended to indicate the location of a vein by revealing variations in the surface temperature of the skin.	A
23	Blood grouping slides	Blood grouping slides are glass surfaces intended to perform the test for finding the blood group.	A
24	Blood bank pipettes	Blood bank pipettes are disposable blood-handling equipment intended to transfer blood from one surface to another.	A
25	Blood mixing and blood weighing devices	A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. Also intended to weigh blood or blood components as they are collected.	A
26	Blood bank centrifuge	Intended to separate blood components of a suspension by application of centrifugal force.	A
27	Heat-sealing device	A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.	A

Category – Operation Theater

S.No	Medical Device Name	Intended Use	INDIA
1	Distractor/Retractors	A surgical device used to separate connected surfaces, and to retain their positions to allow a surgical operation to be performed.	A
2	Suction system portable, Electrical/Pneumatic	A device that generates negative pressure is used for such treatment as the aspiration of liquid or granular substances.	A
3	The suction system is operated by a vacuum	A device used for such treatment as the aspiration of liquid or granular substances by using negative pressure supplied by the hospital’s medical gas supply system at the bedside for use on a patient.	A
4	Operation table system	A device used for such treatment as the aspiration of liquid or granular substances by using negative pressure supplied by the hospital’s medical gas supply system at the bedside for use on patients.	A
5	General-purpose diagnosis/treatment table	A table for general diagnosis and procedures in the examination room to aid in patient examination.	A
6	Surgical light system	An illuminator device intended to provide optimal light and colour rendering to aid in performing surgery.	A
7	Motorized diagnostic imaging view box	A device equipped with an electric mechanical or software-controlled motor that retains, retrieves, and projects light for direct observation of medical images taken using a variety of methods such as X-ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film.	A
8	General-purpose manually-operated operation table	A completely mobile surgical table (general-purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Manual or hydraulic operation	A

Category – Respiratory

A list of Class A Medical Devices under the category of Respiratory is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Airway device cleaning utensils	An assembly of devices designed to concentrate medical grade oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 93%-99.5%, to the hospital medical gas supply system for therapeutic use on patients in the Hospital.	A
2	Airway tube forceps	A hand-held instrument used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways.	A
3	Breathing circuit bag	A device intended to store breathing gas during the respiratory cycle.	A
4	Bulk oxygen concentration system	An assembly of devices designed to concentrate medical grade oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 93%-99.5%, to the hospital medical gas supply system for therapeutic use on patients in Hospital.	A
5	Cardiopulmonary resuscitation mask	A device that is intended to be placed over a patient’s mouth to administer “mouth-to-mask” exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR).	A
6	Cough long-term ambulatory recording system	An assembly of devices intended for long-term detection and recording of the number of times a patient coughs during daily activities or sleep.	A
7	Dry powder inhaler	A hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways.	A
8	Dry salt therapy device	A hand-held inhaler is prefilled with salt crystals and used to provide an inhalation of salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways.	A
9	Endotracheal tube introducer	A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation	A
10	Exhaled-gas oesophageal intubation detector	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation.	A
11	Gas pipeline/supply system air compressor	A device designed to create compressed medical-grade air, and supply it to a hospital or institution’s gas pipeline/supply system for patient use.	A
12	Steam inhaler	An electrically powered, hand-held device designed for the inhalation of steam for the relief of the symptoms (congestion and pressure) associated with upper respiratory disorders	A
13	Stress test treadmill	A device used as a component of a stress test system that permits the evaluation of a patient’s physiologic response to physical stress.	A
14	Therapeutic air ionizer	A device that produces small, biologically active, negatively-charged ions of oxygen (O2), pulsed at various selected frequencies, that are emitted into the ambient air and absorbed into the bloodstream via the lungs to potentially produce a therapeutic effect.	A
15	Tracheostoma protective filter	A device designed as a filter for protecting a stomal opening in the windpipe against harmful external influences.	A
16	Tracheostomy tube lubricant	A substance made of oil is designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula.	A
17	Ultrasonic cough stimulation system	An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency or the very young/elderly, to help clear the lungs of secretions and aspirated materials.	A
18	Valsalva manoeuvre mouthpiece	A device intended to be inserted into a patient’s mouth to facilitate the performance of the Valsalva manoeuvre.	A
19	Video intubation laryngoscope handle/monitor	A component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation	A

Category – Neurological 

A list of Class A Medical Devices under the category of Neurological is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Analytical non-scalp cutaneous electrode	Electrical conductor designed to be attached to the skin surface of a patient outside of the hairline (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring.	A
2	Analytical non-scalp cutaneous lead	Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance].	A
3	Back/leg/chest dynamometer	Intended as a neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior	A
4	Cranial bur,	Intended to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue.	A
5	Cranial trephine,	Intende as a neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior	A
6	Electroencephalograph tester	Intended to perform quality control procedures on an electroencephalograph (EEG) machine and/or a sleep recording machine.	A
7	Esthesiometer.	An esthesiometer is a mechanical device which usually consists of a single rod or fibre which is held in the fingers of the physician or other examiner and is used to determine whether a patient has tactile sensitivity	A
8	Hand dynamometer/pinch meter, electronic	An electronically powered instrument intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object and as part of interactive rehabilitation	A
9	Hand dynamometer/pinch meter, mechanical	A mechanical instrument intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object and as part of interactive rehabilitation.	A
10	Manual goniometer	Intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint.	A
11	Neurosurgical chair	Intended to support and position a patient in a sitting or reclined position during neurosurgery.	A
12	Neurosurgical headrests.	A neurosurgical headrest is a device used to support the patient’s head during a surgical procedure	A
13	Nonpowered neurosurgical instrument.	A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc	A
14	Percussion hammer, manual	l Intended to be used by an examining physician to gently tap near a patient’s joints to test reflexes.	A
15	Percussor.	A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations	A
16	Pinwheel.	A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation	A
17	Pressure algometer/aesthesiometer, electronic	Intended to measure the sensitivity to pain.	A
18	Skull plate anvil	A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient’s skull	A
19	Skull punch.	A skull punch is a device used to punch holes through a patient’s skull to allow fixation of cranioplasty plates or bone flaps by wire or other means	A
20	Skullplate screwdriver.	A skull plate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skull plates to a patient’s skull by screws	A
21	Tuning fork	Intended to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense	A
22	Ultrasonic scanner calibration test block.	An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph)	A

Category – Personal Use

A list of Class A Medical Devices under the category of Personal Use is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Garment, Protective, ForIncontinence	Intended to protect an incontinent patient’s garment from the patient’s excreta.	A
2	Face shield	Intended to protect the wearer’s entire face (or part of it) from hazards such as chemical splashes (in laboratories or in industry), or potentially infectious materials (in medical and laboratory environments).	A
3	Particular respirator,	A disposable medical-grade mask (respirator) is a safety device that covers the nose and mouth and helps protect the wearer from breathing in some hazardous or potentially infectious materials (in medical and laboratory environments).	A
4	Radiation protection gloves	A personal protection device that completely protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures.	A
5	Partial hand radiation protector	A flat pad with straps or partial gloves that protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures.	A
6	Radiation protection apron	A standard-length or half-length apron protects the patient, the operator, and other personnel from radiation exposure during a medical or dental procedure. Some have a fixed or removable collar to protect the neck and thyroid.	A
7	Radiation protection mitten	A personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together.	A
8	Radiation protection goggles	A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment.	A
9	Radiation face protector	A transparent or opaque personal protection device that protects the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.	A
10	Operator radiation protection spectacles	A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. The device comes in non-correction (non-prescription) glasses and visual acuity correction (prescription) glasses.	A
11	Gonadal radiation protector	A personal protection device that attenuates unnecessary radiation exposure in diagnostic, medical or dental procedures, and shields the gonad of the patient and the operator.	A
12	Radiation protection blanket	A personal protection device that protects specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment.	A
13	Radiation protection collar	A personal protection device that protects the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment.	A
14	Radiation protection cap	A personal protection device that protects the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment.	A
15	Mobile radiation protection barrier	A stand-alone, movable barrier that protects the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures.	A
16	Non-latex medical examination glove	Gloves made of synthetic materials, and used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery	A
17	Latex medical examination glove	Natural rubber gloves are used to protect the patient and users from cross-infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery.	A
18	Gown/Coverall	Intended to cover the full body act as impermeable to blood and body fluids and ensure a high level of protection from biological/infectious agents	A

Category – Gynecological

A list of Class A Medical Devices under the category of Gynecological is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Birthing bed/table, powered	Bed used during labour and delivery.	A
2	Foetal stethoscope	A mechanical hearing device is used to listen to fetal heartbeat.	A
3	Gynaecological bib	A piece of cloth was worn by the patient.	A
4	Gynaecological examination	To support a woman’s body in the appropriate positions during gynaecological examinations.	A
5	53 Gynaecological operating tabletop	A component of a modular operating table designed as a detachable table top constructed for gynaecological surgical procedures.	A
6	Gynaecological operating table, electrohydraulic or electromechanical or hydraulic	Active device designed to support a patient during gynaecological surgical procedures	A
7	Heel stirrup	A device used during a medical/surgical procedure to steadily hold a patient’s foot (feet) by cradling the heel or the whole foot.	A
8	Massage oil/cream/gel	Applied to the skin and/or external mucosa to facilitate therapeutic massage.	A
10	Umbilical ligator	surgical device used for umbilical cord ligation.	A
11	Vaginal applicator, reusable or single-use	A device designed to apply medication to the vagina.	A
12	Vaginal lubricant	To lubricate the vagina to facilitate entry of a gloved finger(s) or a device (e.g., a vaginal speculum) during a diagnostic or therapeutic procedure.	A
13	Amniotic membrane perforator, reusable	A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus	A
14	Birthing/delivery kit	A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn	A
15	Menstrual pad, unscented	held in place externally to absorb menstrual or other vaginal discharge.	A

Category – Ophthalmic

A list of Class A Medical Devices under the category of Ophthalmic is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1.	Amsler grid	An ophthalmic device intended to rapidly detect central and paracentral irregularities in the visual field.	A
2.	Anomaloscope	An ophthalmic instrument is used to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects.	A
3.	Automated lensmeter(Dioptometer)	An ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism.	A
4.	Bagolini lens	An ophthalmic plane lens, is intended to determine harmonious/anomalous retinal correspondence.	A
5.	Binocular vision test unit	An ophthalmic device for binocular vision testing	A
6.	Blepharoplasty scissors	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty).	A
7.	Colour discrimination spectacle lens	An ophthalmic lens intended to be worn infringement of the eyes to correct refractive vision conditions and that is coloured/tinted to enhance colour discrimination in patients with colour vision deficiency.	A
8.	Colour discrimination tester	An ophthalmic lamp, is used to test a person’s ability to differentiate between colours.	A
9.	Colour-discrimination eye chart	Intended for testing colour vision.	A
10.	Intended for testing colour vision.	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera.	A
11.	Contact lens radius gauge	A measuring instrument used in ophthalmology to determine the radius of curvature of contact lenses.	A
12.	Diagnostic condensing lens	An ophthalmic lens is used in binocular indirect ophthalmoscopy to focus reflected light from the fundus of the eye.	A
13.	Eikonometer	An ophthalmic instrument for diagnosing aniseikonia.	A
15.	Electronic occlusion spectacles	An ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes	A
16.	Enucleati scissors	A hand-held, manual, ophthalmic surgical instrument used to cut tissue during eye surgery involving enucleation of the eye and/or its related structures.	A
17.	Exophthalmometer	An ophthalmic instrument is used to measure the degree of exophthalmos.	A
18.	Eye irrigation shield	A device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye.	A
19.	Eye pad	A sterile, cushion-like device intended to protect the eye or to absorb eye secretions	A
20.	Eye spud	A hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe.	A
21.	Eyelid clamp	A hand-held manual surgical instrument designed to traumatically grasp and hold the eyelid during an ophthalmic surgical intervention.	A
22.	Eyelid weight, external	An ophthalmic device that is applied to the outside of the upper eyelid to “lidload” the eyelid to restore upper eyelid muscle function.	A
23.	Felt tangent screen	A black tangent screen is intended for assessing the extent of the patient’s peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen.	A
24.	Fibreoptic general-purpose ophthalmic hook	A hand-held manual surgical instrument is inserted into the eye during surgical intervention to manipulate anatomical structures or foreign bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site	A
25.	Fornixscope	A manually-operated, ophthalmic device intended to provide indirect access and viewing of the upper conjunctival fornix and the inner surface of the eyelid as an alternative to eyelid eversion	A
26.	Fresnel lens	A very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions	A
27.	Fresnel prism	A device intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction.	A
28.	Haidinger brush imager	An ophthalmic device designed to produce an image which facilitates his/her visual function evaluation, particularly the macular integrity	A
29.	Hand-held campimeter	A portable, hand-held device intended for assessing the central 30º visual field.	A
30	Hand-held telescope	A device that consists of an arrangement of ophthalmic lenses or mirrors with a handle intended to enlarge images for a visually impaired patient/person	A
31	Hruby fundus lens	A 55-dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slit-lamp illumination and magnification.	A
32	Indirect binocular ophthalmoscope	An ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide-angle, stereoscopic impression of the details of the fundus (retina) and other structures.	A
33	Lens spoon	A hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye.	A
34	Maddox trial lens	A special ophthalmic trial lens in the form of a rod or series of rods (grooves/cylinders) that changes the size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction.	A
35	Mirror-prism spectacles	An optical device intended to enable the patient to see over the top of their head enabling them to look forward in the direction their head is pointing.	A
36	Nystagmus-inducing optokinetic drum	An ophthalmic device intended to elicit nystagmus.	A
37	Nystagmus inducing tape	An ophthalmic device intended to be moved across a patient’s field of vision to elicit optokinetic nystagmus and to test for blindness.	A
38	Ocular occluder	A hand-operated ophthalmic device typically used by an optician/optometrist to temporarily prevent or attenuate (occlude) the passage of light (vision) to one eye, during examination and testing of a patient’s eyesight in the opposite eye.	A
39	Ophthalmic calliper	A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye	A
40	Ophthalmic densitometer	An ophthalmic instrument designed to measure the distance between the cornea and a spectacle or trial lens (vertex distance).	A
41	Ophthalmic examination station	A device assembly intended to provide a complete ophthalmic examination position and support conditions for the patient and clinician	A
42	Ophthalmic head reflector	A head-worn ophthalmic device intended to reflect light onto the eye of a patient to allow examination of the eye and its associated structures.	A
43	Ophthalmic instrument table	A device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments for the examination/treatment of a patient’s eyes	A
44	Ophthalmic surgical device handling forceps	A hand-held manual surgical instrument with blades designed to grasp and manipulate a non-implantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing	A
45	Ophthalmic suture scissors	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut sutures during eye surgery.	A
46	Ophthalmodiastimeter	An ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes.	A
47	Ophthalmoleukoscope	An ophthalmic device intended to be used for testing colour perception through colours produced by polarized light.	A
48	Optical pachymeter	An ophthalmic, device that uses optics to measure the thickness of the cornea.	A
49	Orbital depressor	A hand-held ophthalmic surgical instrument is used to displace tissue to facilitate examination of the surrounding area in the orbital cavity during eye surgery.	A
50	Perimeter	A diagnostic, ophthalmic instrument intended for assessing the extent of the patient’s peripheral visual field.	A
51	Periocular/lacrimal retractor	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention.	A
52	A device that is attached to an ophthalmic spectacle frame to prop open the upper eyelid in cases of ptosis.	An ophthalmic instrument intended to be used to test ocular balance.	A
53	Phoropter	A mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient’s prescription for glasses	A
54	Pleoptophor	An ophthalmic instrument used for the treatment of eccentric eye fixation (casts in the eye) by dazzling the perimacular retina, thereby relatively enhancing the visual capabilities of the fovea.	A
55	Polatest	An ophthalmic device used for evaluating hidden (latent) squinting, i.e., when the patient is not aware of the condition, and also when it cannot be seen.	A
56	Ptosis crutch	An ophthalmic device is used for evaluating hidden (latent) squinting, i.e., when the patient is not aware of the condition, and also when it cannot be seen.	A
57	Pupillograph	A graphic recorder is used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes	A
58	Pupillometer	An ophthalmic device that is worn in front of the user’s eyes to improve their ability to see normally	A
59	Recumbent spectacles	An optical/ophthalmic device that consists of prismatic lenses that is worn in front of the user’s eyes to angle the field of vision enabling the user to read or watch television whilst lying in a supine position.	A
60	Sclerotome	A hand-held manual ophthalmic surgical instrument that is knife-like in design and intended to be used to incise the sclera during a sclerotomy.	A
61	Scotometer	An instrument used for the recording and measuring of the areas of field of vision that is reduced, i.e., relative scotoma, or loss of sensitivity to light (absolute scotoma or blind spots).	A
62	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user.	A
63	Spectacle lens	An ophthalmic device used to correct the refractive errors of that patient’s eyesight and possibly to protect the eyes against radiation or mechanical hazards.	A
64	Spectacle lens curvature gauge	An ophthalmic instrument designed to manually measure the curvature of the surface of a spectacle lens.	A
65	Spectacle-mounted telescope	A device that consists of an arrangement of ophthalmic lenses or mirrors designed to be attached to a pair of spectacles and intended to enlarge images for a visually impaired patient/person.	A
66	Spectacles	An ophthalmic device that are worn in front of the user’s eyes to improve their ability to see normally	A
67	Surgical binoculars	A pair of lenses intended to be mounted onto a surgeon’s spectacles to function as a small telescope and provide a magnified image of the visual field during patient examination or surgical intervention.	A
68	Synoptophor	An ophthalmic device is used for the evaluation and training of a patient’s binocular function.	A
69	Tachistoscope	An ophthalmic device designed to flash words or images at different speeds, for the purposes of ophthalmic diagnostic testing.	A
70	Tinted spectacle lens	An ophthalmic device is used to correct the refractive errors of that patient’s eyesight and to attenuate light radiation by absorption, reflection, or polarization.	A
71	Tinted spectacles	An optical device that contains a pair of tinted spectacle lenses that are worn in front of the user’s eyes to correct the refractive errors of that patient’s eyesight and to attenuate light radiation by absorption, reflection, or polarization.	A
72	Trial lens	An individual ophthalmic lens from a trial lens set	A
73	Trial lens clip	A device used to hold prisms, spheres, cylinders, or occluders on a trial lens frame or set of spectacles during vision testing.	A
74	Trial lens frame	A device used in ophthalmic work for placing, holding, and exchanging trial lenses in front of the eyes of the patient during a sight-testing procedure.	A
75	Trial lens set	A set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction.	A
76	Visual chart	An ophthalmic chart (Snellen chart) is used in testing visual
77	Visual lightbox	A light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) is used for testing visual acuity.
78	Visual projector	An ophthalmic device intended to project an image on a screen to test visual acuity
79	Visual evoked-potential electrode	An electrical conductor intended to record changes in the electric

Category – Rehabilitation

A list of Class A Medical Devices under the category of Rehabilitation is given here:-

S.No.	Medical Device Name	Intended Use	INDIA
1	Acupressure calf band	Intended to be worn around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome.A Non-powered belt like device	A
2	Back pulldown exerciser	Intended to strengthen the muscles of the back (especially the latissimus dorsi) through a repetitive pulldown motion performed with the arms against the force of a weight.	A
3	Back row exerciser	intended to strengthen the muscles of the back through a repetitive rowing motion (as in rowing a boat with oars) performed with the arms against the force of a weight.	A
4	Back/leg/chest dynamometer, mechanical	Non-powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion	A
5	Balance ball exerciser	Intended to be used as an unstable surface on which to perform exercises to improve balance and posture.	A
6	Bicycle ergometer	Intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions.	A
7	Blue/red/infrared phototherapy lamp	Intended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasms, stiffness).	A
8	Body elastic exerciser	Intended to primarily strengthen several or all of the major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance.	A
9	Body flywheel exerciser	Intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel.	A
10	Cold compression therapy cervical spine collar	Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).	A
11	Cold/cool therapy gel	intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.	A
12	Core-body mechanical weight exerciser	Intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation.	A
13	Exothermic heat therapy pack	Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain	A
14	Finger/hand exerciser	intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density	A
15	Gait analysis system	Intended to be used to study walking or running patterns	A
16	Hand dynamometer/pinch meter, mechanical	A mechanical device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object.	A
17	Hydrotherapy treadmill	A powered device intended for use partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to the treadmill walking exercise without increasing the impact and/or stress on the patient’s joints.	A
18	Manual goniometer	A non powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint	A
19	Parallel bar exerciser	Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk	A
20	Standard treadmill, mechanical	Intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness.	A
21	Standard treadmill, powered	Electrically powered unit intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness	A
22	Wall bars	A device that is permanently fixed to the wall intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and the trunk of the body.	A

Category – Physical support

A list of Class A Medical Devices under the category of Physical Support is given here:-

S.No.	Medical Device Name	Intended Use	INDIA
1	Ankle/foot orthosis	Intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve the function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds	A
2	Balance board	Intended to train patients with difficulties in balance (e.g., a paraplegic or a stroke victim) walks for balance training	A
3	Bed traction frame	Intended to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).	A
4	Body arch traction table	Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch.	A
5	Canalith repositioning procedure chair, manual	Intended to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient	A
6	Cervical spine collar	Intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident).	A
7	Cervicothoracic spine orthosis	Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine	A
8	Cervicothoracic lumbosacral spine orthosis	Cervicothoracic lumbosacral spine orthosis	A
9	Collar and cuff arm sling material	Fabric and form composite material intended to immobilize forearm, elbow, humerus or shoulder injuries.	A
10	Cranial orthosis	Intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months	A
11	Elbow orthosis	Intended to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve the function of the elbow.	A
12	Finger orthosis	Intended to encompass the whole or part of the finger to support, align, prevent, or correct deformities/injuries or to improve the function of the finger	A
13	Foot orthosis	Intended to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet	A
14	Hand orthosis	Intended to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve the function of the hand.	A
15	Hand/finger splint	Intended to immobilize an injured hand to protect injuries to, e.g., the digits, metacarpals, and wrist during the healing process.	A
16	Horizontal non-powered traction system	Non-powered device intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae using attached harnesses whilst the patient typically lies in a supine position on the table during treatment.	A
17	Incentive spirometer	Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing.	A
18	Knee immobilizer	Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy	A
19	Orthopaedic bed	Intended to provide support for skeletal traction to stabilize fracture sites	A
20	Paediatric dorsiflexion slant board	Intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) in paediatrics, where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait	A
21	Parapodium walking frame	Intended to encompass and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG)	A
22	Shoulder immobilizer	Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound.	A
23	Swivel-walker	Intended to encompass and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways (shifting their weight from side-to-side with a shoulder movement) which makes the footplate of the device swivel so that it “walks” forward	A
24	Toe separator	Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position	A
25	Wrist immobilizer	Intended to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist.	A

Category –  Interventional Radiology

A list of Class A Medical Devices under the category of Interventional Radiology is given here:-

S.No.	Medical Device Name	Intended Use	INDIA
1	Scintillation(gamma) camera	A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector.	A
2	Positron camera	A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body.	A
3	Nuclear whole-body counter	A nuclear whole-body counter is a device intended to measure the amount of radionuclides in the entire body	A
4	Nuclear rectilinear scanner	A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient.	A
5	Nuclear uptake probe	A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region	A
6	Nuclear whole-body scanner	A nuclear whole-body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient.	A
7	Nuclear scanning bed	A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.	A
8	Nuclear anthropomorphic phantom	A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments	A
9	Nuclear flood source phantom	A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response	A
10	Nuclear-sealed calibration source	A nuclear-sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors	A
11	Nuclear electrocardiograph synchronizer	A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images	A
12	Radionuclide test pattern phantom	A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device.	A
13	Radiographic film marking system	A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.	A
14	Diagnostic x-ray tube housing assembly.	A diagnostic X-ray tube housing assembly is an X-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes.	A
15	Diagnostic X-ray tube mount	A diagnostic X-ray tube mount is a device intended to support and position the diagnostic X-ray tube housing assembly for a medical radiographic procedure	A
16	Radiologic patient cradle	A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.	A
17	Radiographic film	The radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.	A
18	The wall-mounted radiographic cassette holder	A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for radiographic exposure for medical use	A
19	Radiographic film illuminator	A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs	A
20	Radiographic grid	A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor	A
21	Radiographic head holder	A radiographic head holder is a device intended to position the patient’s head during a radiographic procedure	A
22	Radiologic quality assurance instrument	A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device	A
23	Radiographic anthropomorphic phantom	A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.	A
24	Radiographic intensifying screen	A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.	A
25	Radiographic ECG/respirator synchronize	A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.	A
26	Medical image storage device	A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.	A

Category – Dermatology and Plastic surgery

A list of Class A Medical Devices under the category of Dermatology and Plastic Surgery is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Surgical camera and accessories	A surgical camera and accessories is a device intended to be used to record operative procedures.	A
2	Non-powdered surgeon’s glove.	A non-powdered surgeon’s glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination	A
3	Dermatome skin approximation tape	A tape that comes in various sizes with adhesive on both sides. It is attached onto a skin graft knife to collect a skin graft tissue. This device is for single-use.	A
4	Drape adhesive.	A drape adhesive is a device intended to be placed on the skin to attach a surgical drape	A
5	Eye pad	An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.	A
6	Hydrophilic wound dressing.	A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon).	A
7	Internal tissue marker.	An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.	A
8	LaparoscopyTray”	Laparoscopy Tray is intended for single-use to enable a suitable trained health care professional to perform an laparoscopic procedure.	A
9	Manual operating table and accessories and manual operating chair and accessories	A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.	A
10	Manually-operated dermatome	A hand-held surgical device used to sever a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose.	A
11	Occlusive wound dressing.	An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device.	A
12	Plastic surgery osteotome	A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument.	A
13	Reusable dermatome blade	A blade that comes in various sizes, attached to the skin graft knife, and is used to harvest the skin graft. This device is reusable after sterilization. Usually, the blade point should be sharpened periodically.	A
14	Skin marker	A skin marker is a pen-like device intended to be used to write on the patient’s skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.	A
15	Surgical apparel	Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate	A
16	Surgical guillotine	A cutter that consists of a metal frame. The cutter slides through the frame. It comes in various configurations and sizes according to the type of tissue to be severed. Various cranks or shaft driver mechanisms generate the power.	A
17	Surgical lamp	Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient	A
18	Surgical microscope and accessories.	A surgical microscope and accessories is an ACpowered device intended for use during surgery to provide a magnified view of the surgical field.	A

Category – Pediatrics and Neonatology

A list of Class A Medical Devices under the category of Pediatrics and Neonatology is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Assistive ergonomic chair mobility base	A manually-operated, height-adjustable, non-powered, mobile support for an assistive ergonomic chair intended to be used by a healthcare provider/carer to provide mobility for a disabled (often paediatric) patient. It consists of a framework on wheels with a chair/seat mount, a handlebar for the user to hold/push the assembly, and may include a brake; it includes a manually-powered (fully or hydraulically-assisted) chair lifting mechanism. It is not a wheelchair component.	A
2	Exhaled-gas oesophageal intubation detector, paediatric	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during paediatric intubation and is attached between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device.	A
3	Infant care table	A specially made table used for nursing, e.g., washing or changing of nappies, of newborn babies. It can be equipped with a washing basin, typically of soft material (rubberized cloth), and a surface upon which to lie the infant for drying with a towel.	A
4	Infant incubator warming hood	A heating element positioned above an incubator’s chamber designed to provide warmth for the chamber’s environment. It may be used instead of or as a supplement to the incubator’s internal heating system, and may be built onto or be an integral part of the incubator hood.	A
5	Infant inguinal hernia truss	A bandage-like strap of worsted yarn intended to be worn over the groin to prevent protrusion of abdominal contents in an infant with an inguinal hernia. This is a single-use device.	A
6	Infant limb immobilizer, reusable	A non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render parts of an infant’s body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a single-use device.	A
7	Infant limb immobilizer, single-use	An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consists of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.	A
8	Infant scale, electronic	A non-rigid device, usually made of flame retardant fabric and/or polyurethane foam materials, intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent back sleeping position. It is available in a variety of designs including a wedge-shaped head pillow, a sleeping garment (sleeveless vest) with hooks/Velcro fasteners/nylon zip fasteners and an insertable foam wedge, or a specially designed mattress. This is a reusable device	A
9	Infant sleep positioner	A non-rigid device, usually made of flame retardant fabric and/or polyurethane foam materials, intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent backsleeping position. It is available in a variety of designs including a wedge-shaped head pillow, a sleeping garment (sleeveless vest) with hooks/Velcro fasteners/nylon zip fasteners and an insertable foam wedge, or a specially designed mattress. This is a reusable device	A
10	Infant whole-body immobilizer, reusable	A device intended to be used to temporarily render an infant’s whole body immovable (strait-jacket effect) while the patient undergoes therapeutic or diagnostic interventions. It includes non-rigid fabric and/or plastic components but might also include a rigid structural component (e.g., board). This is a reusable device.	A
11	Infant whole-body immobilizer, single-use	A non-sterile, non-rigid device, usually made of a fabric and/or plastic materials, intended to be used to temporarily render an infant’s whole body immovable (strait-jacket effect) while the patient undergoes therapeutic (e.g., phototherapy) or diagnostic interventions. This is a single-use device.	A
12	Infant-hammock bed mattress	A foam-filled case with a central meshed/netted depression/hole designed to be placed in a cot/crib/bassinet/bed/incubator and to cradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. It is available in various shapes and sizes and is not intended to be placed on an existing mattress. The breathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia. This is a reusable device.	A
13	Infant-hammock bed mattress overlay	A portable pad with a central meshed/netted depression designed to be placed on a cot/crib/bed mattress and to cradle a young infant during sleep/rest. The device is typically foam-filled and wedge-shaped with ventilation channels and securing ribbons. The breathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), and hyperthermia. This is a reusable device.	A
14	Microlaryngeal probe	A hand-held manual surgical instrument designed for paediatric laryngology and for phonatory microsurgery applications in adults. This delicate probe gives a precise sense of palpation for accurate detection of	A
15	Neonatal kangaroo care garment	A non-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant in a manner which enables skin-to-skin contact between parent and infant (kangaroo care). It typically consists of a wrap/sweater with a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable garment	A
16	Oxygen administration hood, paediatric	A device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant’s whole body, or the head only, in order to provide an enriched environment of oxygen (O2) to increase the patient’s O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed to be used for patients adverse to oxygen delivery devices such as a nasal cannula or face mask. This device may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors. This is a reusable device	A
17	Paediatric dorsiflexion slant board	A standing platform for a child designed to slant the surface on which the feet are placed to create a slope angle to therapeutically stretch the ankle plantar flexion muscles/tendons. It is intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait. It is typically made of synthetic polymer materials. This is a reusable device.	A
18	Paediatric urine collection/analysis kit	A collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It is intended to be used at the point-of-care by a healthcare professional, or at home by a caregiver. This is a singleuse device.	A
19	Phototherapy eye protector, reusable	A device worn to cover and protect the eyes of a patient or user from potentially harmful rays [e.g., ultraviolet (UV)] to which parts, or all, of their body is intentionally exposed during light therapy treatment. It will typically be designed as goggles, special spectacles, or a mechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will come in a variety of sizes, e.g., premature infant, neonatal, child, and adult. This is a reusable device.	A
20	6 Phototherapy eye protector, singleuse	A device worn to cover and protect the eyes of a patient from potentially harmful rays [e.g., ultraviolet (UV)] to which their body is intentionally exposed during light therapy treatment. It will typically be designed as a mechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will typically be made of soft materials in a variety of sizes, e.g., premature infant, neonatal and affix to the head using bands, hooks, Velcro fasteners, and/or adhesive fasteners. This is a single-use device	A
21	Birthing bath	A large bath intended to be filled with heated water for use before and/or during child birth. It may be used to deliver the baby under water and/or to provide a comfortable environment for the expecting mother prior to birth. The device may also include specific features such as connectors and diagnostic attachments.	A
22	Newborn-infant bed	A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.	A
23	Bedrail pad	A device which is formed as a flat or contoured fitted cushion made of soft, non-irritating materials designed to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that have little self-control, infants and very young children. This is a reusable device.	A
24	Nappy changing table, portable	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support an infant, child or an adult during nappy (diaper) changing. The device is used primarily for a patient with a disability who is incontinent and requires regular changing of their nappies. It is designed to be portable for transport to different locations.	A
25	Nasal aspirator, electric	A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device	A
26	Oral medicine dropper	A device designed for aspirating a small volume of liquid medicine so that it can be dispensed in single drops into a patient’s mouth, typically an infant or small child. It is typically designed as a hollow tube, open at both ends, with an aspiration bulb attached to the proximal end and a narrow opening at the distal end. It is usually made of glass or plastic with a rubber teat. This is a reusable device.	A
27	Oxygen terminal unit	A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for oxygen (O2). It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling pendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect and disconnect a device, typically anaesthesia systems, ventilators, respiratory devices, infant incubators, and other devices that require O2 to function as intended. On disconnection of the medical device from the outlet, it will self seal the gas pipeline system preventing gas leakage to the environment.	A
28	Teething device, non-fluid-filled	A circular or cylindrical device free of fluid and intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.	A

Category – Oncology

A list of Class A Medical Devices under the category of Oncology is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Blepharoplasty scissors	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). It is not intended for intraocular surgery.	A
2	Capsular tension ring	A circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules.	A
3	Brachytherapy radionuclide phantom, anthropomorphic	A device that consists of preserved human or animal tissue, or a two or threedimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs.	A
4	Antimicrobial postsurgical brassiere	A woman’s undergarment which includes antimicrobial properties designed to: 1) support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy);	A
5	Antimicrobial postsurgical female underpants	intended for use during medical treatment (e.g., chemotherapy) or be used to protect the skin following treatment with a medication (e.g., ointment, cream). It is specifically designed for patient support/comfort in the home or healthcare facility. This is a reusable device.	A
6	Brachytherapy radionuclide phantom, test object	A non-tissue configured model designed to mimic the functional/physical characteristics of normal or diseased human organs during performance evaluations of brachytherapy system components or radiation therapy treatment planning devices	A
7	Cervical cytology scraper, reusable	blunt surgical instrument used to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a reusable device.	A
8	Cytotoxic waste receptacle	A device designed as a container to allow the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs).	A
9	Extravascular-circulation hyperthermia system applicator, extracorporeal	A vessel applied to the outside of the body (e.g., in the form of a jacket, vest, body wrap, cushion, blanket, or mattress) that incorporates tubing through which heated fluids are circulated for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. he applicator typically includes a thermometry component that monitors the temperature of the applicator during operation. The applicator includes tubing, cables, and connectors that interface with the hyperthermia system’s control unit during treatments. It is typically used in an oncology department. This is a reusable device.	A
10	Eye brachytherapy system applicator, manual	A device in the form of a template that is shielded on one side and containing grooved positions for manual brachytherapy sources on the other used for the temporary topical application of brachytherapy sources to the surface of the eye	A

Category – Nephrology and Renal Care

A list of Class A Medical Devices under the category of Nephrology and Renal Care is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Chair, Haemodialysis, Electrically powered/Manual.	Intended to support the patient in a seated or reclined posture during haemodialysis procedures	A
2	Crimp for plier, Haemodialysis	Intended to manipulate the arteriovenous shunt of patients required hemodialysis.	A

Category – Software

A list of Class A Medical Devices under the category of Software is given here:-

S.No	Medical Device Name	Intended Use	INDIA
1	Continuous Glucose Monitor Retrospective Data Analysis Software	Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.	A

How Are Class A Medical Devices Regulated?

Class A medical devices are governed by general control to guarantee safety and proper labelling. This includes basic device registration registration with health authorities, helps ensure the quality management system

Can Class A Medical Devices Be Used In Surgeries?

Yes, Some Class A medical devices can be used in surgeries, we can also call them supportive medical devices. For example surgical gloves, and some kinds of drapes. However, more dangerous medical devices directly used for the surgical procedures

How Do Class A Medical Devices Differ From Class B?

Both classes A and B are meant to show risk factors, and in easy words, Class – A medical devices possess low-risk rate and Class – B possess more risk. To understand the comparison between medical device class A and Medical device class – B, check the table given below:-

S.No	Class – A Medical Devices	Class B Medical Devices
1	Exposes Low Risk	Poses High Risk as compared to Class – A
2	Non-Invasive	Minimal Invasive
3	Nose clip, Toe separator, and Eye pad	Respiration monitor, Acupuncture kit and Cold-air therapy unit
4	Need less regulatory requirement	Need strict regulatory requirements as compared to class-A medical devices

What Is The Significance Of Class A Devices In Healthcare?

Class – A medical device are very important in the healthcare industry as it help in basic medical procedures and safety. This class includes basic surgical tools, examination gloves, and bandages, these medical devices are often used in healthcare settings.

What Quality Controls Apply To Class A Medical Devices?

These quality controls are applied on Class – A medical devices:-  

• Manufacturing Standards 
• Quality Management System 
• Product Testing 
• Labelling

Are There Any Labeling Requirements For Class A Devices?

Yes, Class A Medical devices do have labelling requirements, which are not as confusing as Class B medical devices’ labelling requirements. Medical device Class – A should contain basic details like the device’s name, manufacturer’s name, and instructions for usage. The main motive is to provide clear information. 

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What Role Do Class A Medical Devices Play In Patient Care?

Class – A medical device plays a very crucial role in everyday life by offering fundamental support and basic medical treatment. To get a Medical Device Certificate, you can click on it.

Conclusion

In this content we have mentioned a comprehensive list of Class A Medical Devices In India. Through this you can understand which device lies in the Class A of medical device and which approval do you need for the regulatory of Class A Medical Device registration in India.