A class of devices include what

Question 1: What does a class of medical devices include Class I medical devices refers to, through the routine management of sufficient medical devices. In general, where the in vitro application is not in direct contact with the skin or tissue, the structure is relatively simple, the function is relatively single, generally passive (external or built-in power supply or other power source), there is a certain auxiliary or alleviate the symptoms or preventive effect, the potential risk is very small or virtually no risk, without special management can ensure that its medical devices are mostly a class of medical equipment; implanted in the body, in contact with the blood or body fluids The medical devices implanted in the body, in contact with blood or body fluids, external power supply, high power, trauma or radiation and other injuries to the human body, play a major diagnostic, therapeutic or other roles, must be used by specialized or trained personnel to operate or manage in order to ensure its safety, effectiveness, the majority of the potential risks of Class III medical devices; the rest are basically Class II medical devices. The number of Class II devices accounted for 60%, and Class I and III each accounted for about 20%. According to the above principles of judgment, eight or nine. For the classification of specific products attributed to the State Food and Drug Administration website in the "Medical Device Classification Catalog".

Question 2: What is included in a class of medical devices 01. "Medical Device Classification Catalog" description 02.6801 Basic Surgical Instruments

03.6802 Microsurgical Surgical Instruments

04.6803 Neurosurgical Surgical Instruments

05.6804 Ophthalmic Surgical Instruments

06.6805 Surgical Instruments for Ear, Nose and Throat Surgery

07.6806 Surgical Instruments for Oral Surgery

08.6807 Surgical Instruments for Thoracic and Cardiovascular Surgery

09.6808 Surgical Instruments for Abdominal Surgery

10.6809 Surgical Instruments for Uro-anorectal Surgery

11.6810 Surgical Instruments for Orthopedic Surgery

12.6812 Surgical Instruments for Women's and Children's Surgeries

12.6812 Surgical Instruments for Obstetrics and Gynecology

13.6813 Surgical Instruments for Family Planning

14.6815 Injectable and Puncture Instruments

15.6816 Surgical Instruments for Burns (Plastic)

16.6820 General Diagnostic Instruments

17.6821 Electronic Instruments for Medical Use

18.6822 Medical Optical Apparatus, Instruments and Endoscopic Devices

19.6823 Medical Ultrasound Instruments and Related Devices

20.6824 Medical Laser Instruments and Equipment

21.6825 Medical High-Frequency Instruments and Equipment

22.6826 Physical Therapy and Rehabilitation Devices

23.6827 Chinese Medicine Instruments

23.6827 Instruments for Traditional Chinese Medicine

24.6828 Magnetic **** vibration equipment for medical use

25.6830 X-ray equipment for medical use

26.6831 X-ray accessory equipment and components for medical use

27.6832 High-energy ray equipment for medical use

28.6833 Nuclide equipment for medical use

29.6834 Medical ray protection supplies, devices

30.6840 Clinical testing and analyzing instruments

31.6841 Medical laboratory and basic equipment apparatus

32.6845 Extracorporeal circulation and blood processing equipment

33.6846 Implantable materials and artificial organs

34.6854 Operating room

34.6854 Operating room, emergency room, diagnostic and treatment room equipment and apparatus

35.6855 Stomatology equipment and apparatus

36.6856 Ward care equipment and apparatus

37.6857 Disinfection and sterilization equipment and apparatus

38.6858 Cold therapy for medical use, cryogenic, refrigeration equipment and apparatus

39.6863 Stomatology materials

40.6863 Dentistry material

41.

40.6864 Medical hygiene materials and dressings

41.6865 Medical suture materials and adhesives

42.6866 Medical polymer materials and products

43.6870 Software

44.6877 Interventional devices

Question 3: Medical devices a class. How many kinds of products are included in the classification of medical devices Most of the household medical equipment in the classification of medical devices belongs to a class of medical devices, the state control is relatively loose, the application process is also relatively simple, so the feeling is like a general instrumentation, but because it is also an auxiliary means of medical treatment, so it is defined as a medical device. For example, many of the following are:

Home health care equipment Pain *** equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral hygiene and health products, adult home health care equipment

Home health care *** products Motorized *** chairs/beds; ***; *** whack; ** pillow; *** cushion; *** cushion; *** chair/bed; *** whack; *** pillow; *** cushion. *** Pillow; *** Cushion; *** Lumbar Belt; Blood and Qi

Circulation Machine; Foot Bath; Foot *** Appliance; Handheld *** Appliance, *** Bathtub, Fat Dumping Belt;

Therapeutic Instrument; Plantar Physiotherapy Instrument; Weight Loss Belt; Car Seat Cushion; Kneading Cushion; *** Chair; Breast Enhancement Appliance;

Cosmetic *** Appliance.

Home Medical Rehabilitation Equipment Therapeutic Instruments, Kaikang High Potential Therapeutic Instrument, Cervical Spine Therapeutic Instrument, Household Cervical Spine and Lumbar Spine Tractor, Traction Chair, Physiotherapy Instruments, Sleep Instrument, *** Instrument, Functional Chairs, Functional Beds, Supports, Medical Inflatable Air Cushions; Oxygen Generator, Decoctions, Hearing Aids, etc.;

Home Nursing Care Equipment Home Rehabilitation Nursing Care Auxiliary Appliances, Women's Pregnant and Infant Nursing Care Products

Question 4: What is included in a class of medical devices Including: antipyretic patches, bandages, photon cold gel and so on. According to the "supervision and management of medical devices regulations" pointed out that medical devices, refers to the direct or indirect use of the human body instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including the required computer software; its utility is mainly obtained through the physical and other means, not through the pharmacological, immunological or metabolic way to obtain, or although there are involved in these ways (i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;

(ii) diagnosis, monitoring, treatment, mitigation, or functional compensation of injury;

(iii) testing, substitution, modulation, or support of physiological structures or processes;

(iv) support or maintenance of life;

(v) support or maintenance of life;

(vi) support or maintenance of the environment;

(vii) support or maintenance of the environment;

(viii) support or maintenance of life. p>

(v) Pregnancy control;

(vi) Providing information for medical or diagnostic purposes through the examination of samples from the human body.

Article IV of the State of medical devices in accordance with the degree of risk to implement classification management.

The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.

The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.

The third category is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.

Question 5: What is a class of medical devices Hello, the first class of medical devices refers to the routine management of medical devices to ensure their safety and effectiveness.

In the "Classification of Medical Devices Catalog" in the following classification of a class of medical devices

Basic surgical instruments microsurgical instruments

Neurosurgical instruments ophthalmic surgical instruments

ENT surgical instruments oral surgical instruments

Thoracic cardiovascular surgical instruments abdominal surgical instruments

Urology and anorectal surgery

The first class of medical devices is the first class of medical devices, and the second class is the first class of medical devices, and the third class is the second class of medical devices. p> Urological and intestinal surgical instruments Orthopedic (orthopedic) surgical instruments

Obstetrics and gynecology surgical instruments Family planning surgical instruments

Injection and puncture instruments Burns (plastic) surgical instruments

General diagnostic instruments Medical electronic instruments and equipment

Medical optical instruments, instruments and endoscopic equipment Ultrasound instruments and related equipment

< p> Medical laser instruments and equipment Medical high-frequency instruments and equipment

Physical therapy and rehabilitation equipment Chinese medicine instruments

Medical magnetic **** vibration equipment Medical X-ray equipment

Medical X-ray accessory equipment and components Medical high-energy radiation equipment

Medical nuclide equipment Medical ray protection supplies, devices

Clinical testing and analysis equipment Medical Laboratory and basic equipment and instruments

Extracorporeal circulation and blood processing equipment implantable materials and artificial organs

Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances

Ward care equipment and appliances disinfection and sterilization equipment and appliances

Medical cold therapy, cryogenics, refrigeration equipment and appliances stomatology materials

Medical Hygiene materials and dressings medical suture materials and adhesives

Medical polymer materials and products interventional devices

The following products are Class I medical devices: stethoscopes, percussion hammers, reflective instruments, vision diagnostic instruments, oral knife, chisel, oral pliers, corneal clippers, ophthalmic surgical scissors, ophthalmic tissue scissors, microscopic clippers, micro-gun surgical scissors, micro-tissues clippers, film frames, skyrail Hanger, X-ray photography dark box, film washing frame, X-ray darkroom equipment

Question 6: What is included in a class of medical devices Check the classification of a class of medical devices catalog

Question 7: What is included in a class of medical devices A class of medical devices: through the routine management of the sufficient to ensure its safety, effectiveness. Such as most of the surgical instruments, stethoscopes, surgical caps, masks, medical X-ray film, wound post and so on.

Question 8: What is included in a class of medical devices A. According to the "Regulations for the Supervision and Administration of Medical Devices"

Article IV of the State of the medical devices in accordance with the degree of risk to implement the classification management.

The first class is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.

The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.

The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.

Second, on the solicitation of "Product Catalog of Class I Medical Devices" (draft) and the medical device classification catalog part of the subdirectory of the revision of the letter , to the official website of the State Food and Drug Administration to query this article, which has an appendix.

Question 9: What does Class I medical device include? Basically, it is some surgical instruments used in hospitals, such as surgical instruments and suture materials for surgery, ophthalmology, otolaryngology, etc., and adhesives, as well as artificial organs and so on.

Question 10: a class of medical devices include a class of instruments including surgical instruments, stethoscopes, medical x-ray film, medical x-ray protection, automatic electrophoresis, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, elastic bandages, polymer bandages, plasters, band-aids, cupping, surgical gowns, surgical hats, masks, collection of urine bags and so on.