CDSCO risk classification
General Hospital medical device classification
Every general hospital device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 32 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 74
- Class A
- 41
- Class B
- 24
- Class C
- 6
- Class D
- 3
General Hospital devices and their class
74 devices
Acupressure Stimulation Patch
General Hospital
Class ANon-sterile, non-measuringA disposable adhesive patch intended to be applied on acupressure points (e.g., behind earlobes, etc.) on intact skin to temporarily relieve vomiting, nausea, and/or other symptoms associated with motion sickness. This may contain (non-medicinal) herbal extracts. This does not contain any medicinal/pharmaceutical drug. Supplied non-sterile.
Adhesive synthetic polymer semi-permeable film dressing
General Hospital
Class BA sterile, single-use wound covering that is transparent, semi-permeable covering, applied to wounded or diseased tissue, intended to provide protection (e.g., from dirt, water) and/or promote healing. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It does not contain antimicrobial.
Airborne Disinfectant Spraying Device
General Hospital
Class ANon-sterile, non-measuringA powered, mobile, empty device intended for use in healthcare and clinical settings for containing and automated dispersion/spraying of an appropriate disinfectant [e.g., hydrogen peroxide (H2O2), colloidal silver, etc.] into the atmosphere of an enclosed area [e.g., operating room, intensive care units, infected patient rooms, burn units, examination/treatment room, etc.] to destroy harmful microorganisms and hard surface decontamination. The disinfectant is not included. It is not intended for disinfection or sterilization of medical devices.
Alternating-Pressure Bed Mattress System
General Hospital
Class ANon-sterile, non-measuringAn assembly of devices, consisting of an alternating-pressure bed mattress and a dedicated electric pump (control unit), intended to actively alternate a bed occupant's bed-contact points, to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized, patients with disabilities, or patients with low body fat.
Autologous Exosome Isolation Kit, single-use
General Hospital
Class BA set of non-powered devices (such as syringes, filters, needles, vacutainer tubes, long hypodermic needle, filters, connectors) intended for isolation of exosome-rich plasma from blood and its autologous administration into the body, for various purposes such as correction of wrinkles or skin tone, improvement of sun-damaged skin, revitalization of hair follicles, orthopedic applications, or other regenerative purposes, etc. This does not contain anticoagulants, hyaluronic acid, or any other bioactive substances for infusion into the body. This is a single-use device.
Automatic Endoscope Pre-Cleaning/Washing System
General Hospital
Class ANon-sterile, non-measuringA powered device intended to pre-clean/wash compatible endoscopes using detergent (not included) prior to their sterilization/disinfection. It is designed to automate the manual scrubbing/brushing task performed for endoscope cleaning. It is not intended for disinfection/sterilization. This is a reusable device.
Blood Bag Tube Welder
General Hospital
Class ANon-sterile, non-measuringThe device is a powered, reusable equipment intended for use in healthcare facilities for the connection of tubes of two blood bags to create a sterile weld between two segments of tubing, associated with blood or blood component transfer systems.
Blood collection tube holder with safety shield
General Hospital
Class ANon-sterile, non-measuringA non-invasive, non-powered accessory of a blood collection tube and venipuncture needles [not included], intended to hold the blood collection tube during venipuncture and shield the puncture needle just after venipuncture, thereby reducing the risk of accidental needle stick injuries during handling and disposal. This is supplied non-sterile and is intended for single-use.
Blood Component Extractor (Separator), automated
General Hospital
Class ANon-sterile, non-measuringA powered blood bank equipment intended for the automated separation of previously centrifuged blood into components [e.g., red blood cells (RBCs), platelets, leukocytes] for further processing or storage. It is NOT to be used during the blood collection process with the donor/patient still connected to the needle. It does not come in direct contact with blood and does not have any centrifuge/adsorption columns for blood component separation. Not intended for processing of whole blood.
Blood Lancet, single-use
General Hospital
Class BA sterile, hand-held manual instrument intended for controlled skin puncture, typically at the fingertip, to obtain a capillary blood specimen for diagnostic or monitoring purposes. This is a single-use device.
Blood Lancing Device, without lancet, reusable
General Hospital
Class ANon-sterile, non-measuringA hand-held, non-invasive, manual instrument intended to be used with a lancet [NOT included] for controlled skin puncture to obtain a capillary blood specimen at the fingertip or ear lobe. It may work on a spring-loaded mechanism. This does not include lancet or puncture needle. This is a reusable device.
Blood/Blood Product Thawing Unit
General Hospital
Class ANon-sterile, non-measuringA powered device, designed as a waterbath, intended for use in blood banks, hospitals, etc. as an aid in speeding up thawing of freshly frozen blood or blood products in a controlled manner. It is NOT intended to warm the blood prior to infusion to a patient or for inline heating.
Blood/Body Fluid Solidification Device
General Hospital
Class ANon-sterile, non-measuringA non-sterile substance intended to be used to absorb and solidify blood and/or other body fluids (such as sputum, urine, vomit, etc.) or other biohazardous liquids such as veterinary fluids, laboratory and hospital liquid waste, etc., for their safe disposal. It may be standalone or available in containers such as urine bags, vomit bags, sputum/spit cups, suction canisters, etc. This is a single-use device
Body Composition Analyzer
General Hospital
Class BAn electronic device intended to estimate and measure body composition (i.e., body weight, percent body fat, bone density, muscle (lean) mass, and/or hydration, etc.) using bioelectrical impedance analysis (BIA) and other user inputs (such as age, height, etc.). It consists of a main unit with electrodes applied to intact skin. It may also be in the form of a scale(s) placed on the floor, upon which the patient stands to measure total body weight. This is a reusable device.
Bone Marrow Biopsy Needle, single-use
General Hospital
Class BA hand-held device intended for harvesting bone marrow (and/or bone) specimens for pathological examination (biopsy, blood testing, etc.). This is a single-use device.
Cabin Spray Vaccinator
General Hospital
Class AA veterinary-use device intended to generate and deliver a controlled aerosol of loaded veterinary medicinal product (such as vaccines and other similar drugs), within enclosed animal housing environments for the purpose of mass vaccination.
Circumcision Ring
General Hospital
Class BA non-powered, non-surgical device intended to be worn by male individuals to remove foreskin on the penis. This is a single-use device and not intended for long-term use.
Class II Biological Safety Cabinet
General Hospital
Class ANon-sterile, non-measuringA powered device intended for use in hospitals and healthcare settings to provide class II biosafety level (BSL) to the operator, the product, and the environment during the manipulation of microorganisms, extremely toxic materials (e.g., chemotherapy agents), and other biological hazardous materials (usually up to category 3 pathogens). It has controls and displays for parameters such as UV run time, HEPA filter run time, airflow velocity, etc. This is not intended for use in education, training, or other general laboratory purpose uses.
Cold therapy patch
General Hospital
Class ANon-sterile, non-measuringA non-sterile patch/strip consisting of a jelly-like substance and purified water, intended for localized topical skin application to provide a cooling effect as an aid in relieving fever and associated discomfort. This does not contain any pharmaceuticals or self-heating chemicals. This is a single-use device.
Display Monitor
General Hospital
Class ANon-sterile, non-measuringAn electrically powered medical device used for displaying medical images generated by compatible medical imaging systems for review and interpretation by trained/qualified medical practitioners. It does NOT contain any operation software or primary image output software for medical imaging systems.
Dry Cleaning Wipe
General Hospital
Class ANon-sterile, non-measuringA non-sterile, disposable, nonwoven wipe intended for cleaning, wiping, drying, and absorbing fluids from intact skin, medical devices, and surrounding surfaces during medical and surgical procedures. The wipes may also be used with compatible antiseptic, disinfectant, or saline solutions for external cleaning purposes. It does NOT include any disinfectant or medications. This is NOT intended for end-point sterilization/disinfection. This is a single-use device.
Electrical Impedance Tomography System
General Hospital
Class BA portable device, consisting of a wearable electrode array, a control system and a software application, intended for use in healthcare/homecare settings to visualize and assess internal organ health, including liver, kidney and lungs, using Electrical Impedance Tomography (EIT) technology. This is not intended for diagnosis. It is an adjunct aid for screening of vital organ functions.
Electrocardiographic (ECG) lead set, reusable
General Hospital
Class ANon-sterile, non-measuringA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode (not included) attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It may include a trunk cable with connector. It does not include ECG electrodes. This is a reusable device.
General-purpose absorbent tip applicator/swab
General Hospital
Class ANon-sterile, non-measuringA non-sterile cotton bud or swab, in the form of a stick with absorbent tip, intended for absorption of body fluids from superficial cuts/punctures (e.g., during or after finger-prick tests) and cleaning of skin. It does not contain alcohol or other medicinal substances. It is NOT intended for sample collection for further testing.
Growth Factor Concentrate (GFC) Tube
General Hospital
Class BA sterile container intended to temporarily store blood and subsequently placed in a centrifuge to produce growth factor concentrate (GFC)-enriched plasma/serum for autologous application to the patient for regenerative purposes such as aesthetic dermatology, trichology (hair regrowth), etc. This may contain a clot activator (e.g., CaCl2). This does not contain any other bioactives/additives. This is a single-use device.
Hand-held pupillary examination light
General Hospital
Class ANon-sterile, non-measuringA non-invasive, active hand-held device intended to provide focused illumination for diagnostic examination of eye by healthcare professionals. It is primarily used for assessing pupillary light reflex.
Hot Water Bottle
General Hospital
Class ANon-sterile, non-measuringAn empty container intended to be filled with hot water, to apply heat to an area of the body for therapeutic purposes. This is a reusable device.
Image Display Unit
General Hospital
Class ANon-sterile, non-measuringA powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., LCD monitor, etc.], intended to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical camera systems and display graphical information (e.g., values or images measured/acquired by other devices). The device(s) that generate the visual data are not included with the display unit, i.e., it is not the primary image processing unit of a medical imaging/therapy device. It is a medical-grade monitor intended for use in healthcare settings.
Infusion Pump Multi-outlet Holder
General Hospital
Class ANon-sterile, non-measuringA powered component of an infusion supervision system, consisting of a mounting pole (typically floor-standing type) and multiple electrical outlet sockets, intended to support, carry, transport and provide electrical connection to multiple infusion/syringe pumps. It does NOT include infusion monitoring/alert mechanisms or any monitoring software. It does not control/influence the operation of the infusion pumps.
Insulin Cool Pouch
General Hospital
Class ANon-sterile, non-measuringA non-invasive, non-active, reusable temperature-maintaining/cooling device intended for the storage and transport of insulin and other temperature-sensitive medicinal products. Its principal function is the passive physical maintenance of an appropriate storage environment, without administering, modifying or otherwise acting directly upon the medicinal product.
Intermittent Venous Compression System
General Hospital
Class BA powered device, consisting of a pneumatic pump and inflatable sleeves, intended for intermittent application of pressure to a patient's arms or legs to promote venous blood flow at timed intervals for noninvasive treatment and prevention of venous/lymphatic disorders (edema, deep vein thrombosis (DVT), etc.). It consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s)/sleeves or suit.
Intravenous Gravity Infusion Regulator/Monitor
General Hospital
Class BA powered, non-invasive device intended to monitor, display and/or mechanically regulate the flow rate (within preset ranges) and/or volume of intravenous (IV) fluids administration during gravity infusion. It may also provide an alarm (visible/audible) when pre-set limits are exceeded. It may be IoT-enabled for wireless transmission of data to an externally connected display device. This is NOT intended for use with or replace an infusion/syringe pump. It does not modify the infusion parameters preset by the healthcare professionals.
IV Cannula Fixator, non-sterile
General Hospital
Class ANon-sterile, non-measuringA non-sterile device intended to be applied to a part of a patient's body and held in place by adhesive to secure IV cannula to the skin, cover and protect clean, closed postoperative wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It does not contain antimicrobials and not intended for deep wounds. It is not an adhesive tape or Band-aid. This is a single-use device.
Jaw Physiology Evaluation System, electromyographic
General Hospital
Class BA powered device intended for electromyographic monitoring and recording of parameters for mandibular and muscles of mastication function, to aid in the diagnosis and treatment of craniofacial disorders (e.g., temporomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, etc.), and for orthodontic, denture, and reconstruction patient evaluation.
Laparoscopic Port Closure Device/Needle, reusable
General Hospital
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended for passing sutures [not included] through an incision for its closure after laparoscopic procedures. This is a transient-use, reusable device supplied non-sterile.
Medical Device Disinfection/Cleaning Wipe
General Hospital
Class BA fabric pre-soaked with medical device cleaning/disinfection agents (e.g., isopropyl alcohol, detergents, etc.) for cleaning/surface disinfection of external surfaces of medical devices. This is not intended for end-point disinfection or sterilization of medical devices. This is a single-use device.
Medical Instrument Drying Cabinet/Chamber
General Hospital
Class AA powered device intended for use in healthcare settings (hospitals, clinical labs, etc.) for drying of medical instruments and devices (such as forceps, scissors, trays, respiratory devices, etc.) at controlled temperature after washing/disinfection and prior to sterilization or storage. It contains a control display for controlling, monitoring and display of drying temperature and other operational parameters (such as time, etc.). This is not intended for disinfection/sterilization. This is a reusable device.
Medical Refrigerator/Freezer
General Hospital
Class BA powered device intended for safe storage and preservation of blood/blood products at controlled temperatures. It can also be used to store temperature-sensitive biological samples, vaccines, reagents, pharmaceutical and medical products, etc. Intended for use in healthcare and clinical settings only.
Multiple physiological parameter spot-check system
General Hospital
Class BA powered device intended to spot check and monitor several vital physiological parameters for routine testing, including Oxygen Saturation (SpO₂), Pulse Rate (PR), Blood Pressure (BP), Respiration Rate (RRa), Body Temperature (T) and Heart Rate Variability (HRV). This is not intended for use in critical care or emergencies. This is not intended for continuous monitoring. This can be used in either healthcare or homecare settings.
Nebulizing System Delivery Set
General Hospital
Class BA collection of devices intended to be connected to a nebulizing system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patient's respiratory system. It includes a single-use nebulizing medication chamber, and typically flexible tubing with connectors and/or a mask [e.g., oxygen (O2) mask] or mouthpiece; pharmaceuticals and nebulizer compressor are not included. This may be a single-use, disposable or reusable, single-patient device.
Needle-free Valve Connector
General Hospital
Class BA non-powered accessory to an IV administration set intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set, etc.] and hold them in a secured, sealed, locked position. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.
Negative-pressure wound therapy dressing, antimicrobial
General Hospital
Class DA foam dressing intended to be placed into a wound during a vacuum-assisted wound closure procedure (negative pressure wound therapy (NPWT)) to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts, including infected, necropathic and dehisced surgical wounds. It contains an antimicrobial agent (e.g., silver, etc.) for microbial load management. This is a single-use device.
Non-invasive blood pressure (NIBP) Cuff
General Hospital
Class ANon-sterile, non-measuringA non-sterile, inflatable band-like device, with tubings and connectors, intended to be tied around a patient's arm and connected to a sphygmomanometer or a patient monitoring device/system to determine a patient's blood pressure.
Odour Absorbent Wound Dressing, antimicrobial
General Hospital
Class DA pad covering intended for the management of critically infected, colonized or malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours (typically through a layer of activated charcoal), and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-use device.
Odour Absorbent Wound Dressing, non-antimicrobial
General Hospital
Class CA dressing intended for use with wounds with moderate to heavy exudate, infected or malodourous wounds or lesions to absorb the bad odours typically through a layer of activated charcoal; it does not include an antimicrobial agent(s). This is a single-use device.
Ophthalmic Cleansing Wipe, sterile.
General Hospital
Class AA sterile device, consisting of an absorbent fabric presoaked in liquid solution (purified water/saline, aloe vera, plant extracts), intended for postsurgical cleansing of eyes (periocular area). It may also be used for cleaning of sensitive skin, including cleaning of periocular area of newborns and infants, sensitive skin of lactating mothers, etc. This is not intended as a wound dressing and does not contain any antimicrobial/pharmaceutical/antiseptic agents. This is a single-use device
Oral Suction Toothbrush, single-use
General Hospital
Class AA sterile device intended for suctioning sputum from the oral cavity of patients who are bed-ridden, in coma, abrosia, or suffering mechanical ventilation, etc., as an aid in preventing infections. This may consist of tubings for connection to the suction pump (not included). This is not intended for use in dental interventions. This is a single-use device.
Orthopaedic Internal Fixation Kit for Small Fragments, reusable, measuring
General Hospital
Class AA collection of hand-held, manual instruments (e.g., drills, drill guides, depth gauges, taps, screwdrivers, reduction forceps, plate benders, and countersinks, etc.) intended to be used for the fixation of fractures, osteotomies, and bone deformities in small bones, including those of the hands, wrists, feet, and ankles, etc., as well as for the treatment of non-union or malunion fractures. This consists of measuring devices (e.g., depth gauges). This does not contain bone implants. This is a transient use, reusable device.
Orthopaedic Internal Fixation Set for Long Bones (with implant)
General Hospital
Class CA collection of hand-held, manual instruments (e.g., drills, drill guides, depth gauges, taps, screwdrivers, reduction forceps, plate benders, and countersinks, etc.) devices intended to be used for the he surgical fixation and stabilization of fractures of long bones (e.g., tibia, femur, etc.), by enabling precise insertion and alignment of the bone nail to ensure optimal bone healing and stability. This consists of measuring devices (e.g., depth gauges) and bone implants (e.g., bone screws, fixation bolts, etc.).
Ozone/Ultraviolet Disinfector for PAP systems
General Hospital
Class CA powered device intended for the end-point disinfection of positive airway pressure ventilation unit (CPAP/BPAP) components such as masks, hoses, tubing, and water chamber, etc., using ozone gas/ultraviolet (UV) light as the disinfecting agent. This is a reusable device.
Patient Temperature Probe
General Hospital
Class BA specialized medical sensor intended to be placed on the skin or body orifice to measure and continuously monitor a patient's body temperature in conjunction with a parent device (e.g., multiparameter monitor, etc.) in clinical settings.
Patient Warming Unit
General Hospital
Class BA powered device, consisting of a control unit and a patient-contact mattress/blanket, intended to provide heat to a patient body through the blanket/mattress for preventing hypothermia and maintaining the core body temperature of the patient.
Peristomal/periwound dressing
General Hospital
Class ANon-sterile, non-measuringA non-sterile substance or material intended to be applied to peristomal and/or periwound skin to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. It is not a wound dressing. After application, this device cannot be reused.
Platelet-Rich Fibrin (PRF) Tube
General Hospital
Class AA sterile, empty container intended to temporarily store venous blood and subsequently placed in a centrifuge to product platelet-rich fibrin (PRF) for autologous application to the patient. This is a single-use device.
Platelet-rich Fibrin Matrix (PRFM) Tube with gel
General Hospital
Class BA sterile container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet-rich fibrin matrix (PRF) for autologous application to the patient for regenerative purposes. This contains a separator gel/filter to separate the blood components during centrifugation. This may also contain an anticoagulant to slow down blood clotting. This is a single-use device.
Platelet-rich Plasma (PRP) Tube, with gel
General Hospital
Class BA sterile container, which may contain an anticoagulant, intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet-rich plasma (PRP) for autologous application to the patient for regenerative purposes. This contains a separator gel/filter to separate the blood components during centrifugation. It does not contain any biologicals or additives (other than anticoagulant). This is a single-use device.
Pneumatic Tourniquet Cuff, reusable
General Hospital
Class ANon-sterile, non-measuringA non-sterile device intended to be inflated using a compatible pneumatic tourniquet system (not included) to temporarily restrict blood flow to a specific area of the body, typically a limb, for surgical and orthopaedic procedures. This does not include pressure monitoring device. This is a reusable device.
Point-of-care Health Monitoring Device
General Hospital
Class CAn integrated system equipped with multiple In-vitro diagnostic devices and IoT-enabled medical devices, intended to measure vital parameters, such as SpO2, blood pressure, blood glucose, and other parameters. It is intended to collect and analyze health data to assist healthcare professionals in screening individuals for potential health conditions.
Pre-Operative Kit, non-sterile
General Hospital
Class ANon-sterile, non-measuringA collection of disposable personal protective garments, including as patient gown, bouffant cap, shoe cover, leggings, towels, eye cover, intended for use in medical settings to be worn by the patient/medical professional during aseptic medical management procedures. This does not contain any medications/medicated equipment. This is supplied non-sterile.
Pulse oximeter probe, single-use
General Hospital
Class CA non-invasive device intended to be applied externally to a body site and used in conjunction with a parent device (such as pulse oximeters, patient monitors, etc.) for measuring and continuous monitoring of arterial oxygen saturation (SpO₂) and pulse rate. This is a single-use device.
Scented Pen
General Hospital
Class ANon-sterile, non-measuringA hand-held, non-powered accessory intended to be externally attached to a medical face mask to provide a mild, pleasant aroma during mask use to improve mask acceptance and patient cooperation during sedation.
Semi-Permeable Film Dressing, antimicrobial
General Hospital
Class DA sterile dressing incorporating an antimicrobial (e.g., chlorhexidine, etc.) intended to cover and protect catheter sites and to secure devices to skin. This is a single-use device.
Semi-Permeable Film Dressing, synthetic polymer
General Hospital
Class AA sterile, transparent, semi-permeable dressing intended to applied to superficial wounds and/or clean and closed postsurgical incisions to provide compression, protection, and/or maintaining a moist environment to promote healing. It may have an adhesive layer. It may be used as a secondary dressing over other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is not intended as primary dressing for moderate to heavily exudating wounds/surgical incisions/burns. This is a single-use device.
Sterilization Pack Sealing Unit
General Hospital
Class ANon-sterile, non-measuringA powered device intended to be used for sealing sterilization pouches/bags containing sterilized medical instruments/equipment, through the application of heat to create an airtight seal that maintains sterility of the sealed medical instrument until opened for further use. Intended for use in healthcare settings (e.g., operating room (OR) departments, medical clinics, dental clinics, etc.).
Surgical instrument cleaning brush/wire, reusable/single-use
General Hospital
Class ANon-sterile, non-measuringA non-powered, non-sterile, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to mechanically clean the exterior and/or interior (lumen) of a surgical instrument. This may be a reusable or a single-use, disposable device.
Thoracic suction collection container
General Hospital
Class BA non-powered device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates graduated chambers designed for fluid collection, water seal, and suction control and a suction regulator, air leak indicator, and connection tubing. This is a single-use device
Ultrasonic-cleaning water bath
General Hospital
Class AA powered device intended for cleaning medical instruments by the emission of high-frequency sound waves transmitted through a water bath. It is not intended for sterilization or disinfection of medical devices. It does not include disinfectants.
Venous Tourniquet
General Hospital
Class ANon-sterile, non-measuringA non-sterile device, in the form of a narrow strap/band, intended to be wrapped and manually tightened around a patient's limb to control/stop blood flow during collection of blood from a vein or procedures such as venous cannulation. It may also be used for temporary control of blood flow during first-aid or emergency situations.
Veterinary Endoscopic Artificial Insemination Gun
General Hospital
Class BA powered device, consisting of a mechanical gun integrated with an endoscopic camera, intended for controlled deposition of semen into the reproductive tract of dairy animals (cows, buffaloes, etc.), with real-time visual guidance provided by the endoscopic camera. The camera may also aid in observing uterine involution, detection of metritis and other abnormalities. This is intended for use by trained veterinary professionals.
Veterinary Insemination Sheath
General Hospital
Class AThe device is a sterile, single-use, veterinary insemination sheath intended to cover an artificial insemination gun or manual insemination catheter during use. It acts as a protective hygienic barrier, preventing cross-contamination between animals and maintaining aseptic conditions during the insemination procedure. The sheath facilitates the safe and controlled delivery of semen by enabling smooth insertion and reducing the risk of trauma.
Vial connect holder, reusable
General Hospital
Class ANon-sterile, non-measuringA non-sterile device intended to dock (hold in place) and stabilize a medication vial and syringe to assist in transfer of medication from the vial to the syringe. This is not intended for sterile use.
Wound Irrigation Solution, non-antimicrobial
General Hospital
Class BA solution intended for irrigation, debridement and cleaning of acute and chronic wounds by physical/mechanical means to support natural healing. It is not intended to provide antimicrobial activity. This is not a saline solution. It is not intended for use as instillation buffer during Negative Pressure Wound Therapy (NPWT) or irrigating body cavities.
Wound Irrigation Solution, with Hypochlorous Acid and Neutral pH
General Hospital
Class CA liquid solution that includes hypochlorous acid (or, sodium hypochlorite) intended for use in the debridement, irrigation and moistening of acute and chronic wounds, ulcers (stage I-IV), cuts, abrasions and burns, to support natural healing. The action of hypochlorous acid is ancillary to the use of the irrigation solution.
Wound-non adherent permeable dressing, non-antimicrobial
General Hospital
Class BA sterile, non-resorbable wound covering, in the form of a porous (mesh-like) network impregnated/coated with a substance (or made with a substance such as silicone, petrolatum, paraffin, etc.) that prevents adherence to the wound, intended for atraumatic dressing of superficial burns, minor surgical or traumatic wounds, skin graft donor sites, and other moist or mildly exuding wounds. It may be used with a secondary dressing for absorption of exudates, if any. It does not contain any antimicrobial. It is NOT intended for use with deep, chronic wounds, infected/necrotic wounds or moderate to heavily exudating wounds.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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