Question 1: What are the first-class medical devices? The first category of medical devices refers to medical devices that are fully managed through daily management. Under normal circumstances, any external medicine does not directly contact with skin or tissue, and its structure is relatively simple, its function is relatively simple, and it is generally passive (external or internal power supply or other power supply), which has certain auxiliary or relieving symptoms or preventive effect, and the potential risk is little or no, so it can be guaranteed that its medical devices are mostly a kind of medical devices that do not need special management; Implanted in the body, in contact with blood or body fluids, with external power supply and high power, which causes trauma or radiation damage to people and plays a major role in diagnosis, treatment or other functions, most of the three types of medical devices must be operated or managed by specialized or trained personnel to ensure their safety and effectiveness, with great potential risks; The rest are basically second-class medical devices. The number of secondary instruments accounts for 60%, and the number of primary and tertiary instruments accounts for about 20% respectively. Judging from the above principles, it is close to ten. For specific product classification, please refer to the medical device classification catalogue on the website of the US Food and Drug Administration.

Question 2: What are the first-class medical devices? 0 1. Description of medical equipment catalogue 02+38+0 Basic surgical equipment.

03.6802 Microsurgical instruments

04.6803 neurosurgical instruments

05.6804 Ophthalmic surgical instruments

06.6805 Otolaryngology surgical instruments

07.6806 Dental surgical instruments

08.6807 thoracic cardiovascular surgical instruments

09.6808 Abdominal surgical instruments

10.6809 surgical instruments for uroanorectal surgery

1 1. 10 orthopedic surgical instruments

12.6438+02 Obstetrics and Gynecology Surgical Instruments

13.438+03 family planning surgical instruments

14.6438+05 injection puncture instrument

15.6438+06 surgical instruments for burns (plastic surgery)

16.6820 universal diagnostic instrument

17.6338+0 medical electronic instruments and equipment

18.6822 medical optical instruments, instruments and endoscopic equipment

19.6823 medical ultrasonic instruments and related equipment

20.6824 Medical laser instruments and equipment

2 1.6825 medical high-frequency instruments and equipment

22.6826 Physical therapy and rehabilitation equipment

23.6827 Chinese medicine equipment

24.6828 medical magnetic vibration equipment

25.6830 medical x-ray equipment

26.6438+0 medical x-ray accessory equipment and components.

27.6832 medical high-energy ray equipment

28.6833 medical radionuclide equipment

29.6834 Medical radiation protection articles and devices

30.6840 Clinical inspection and analysis instruments

3 1.645438+0 medical laboratory and basic equipment and appliances

32.6845 Extracorporeal circulation and blood treatment equipment

33.6846 Implants and artificial organs

34.6854 Operating room, emergency room and clinic equipment and appliances.

35.6855 Oral equipment and appliances

36.6856 Ward nursing equipment and appliances

37.6857 Disinfection and sterilization equipment and appliances

38.6858 Medical cold therapy, cryogenic and refrigeration equipment and appliances.

39.6863 dental materials

40.6864 Medical sanitary materials and dressings

4 1.6865 medical suture materials and adhesives

42.6866 medical polymer materials and products

43.6870 software

44.6877 Interventional equipment

Question 3: Medical devices. Including those products, how many kinds of home medical devices are there? In the classification of medical devices, most of them belong to a class of medical devices. The country is relatively loose in management and the application procedures are relatively simple, so it gives people the impression of ordinary equipment, but because it is also an auxiliary means of medical treatment, it is defined as medical equipment. For example, many of the following are:

Family health care equipment pain equipment, family health care self-checking equipment, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral hygiene products, adult family health care equipment.

Electric chair/bed for household health products; *** ; * * * sigh; * * * pillows; * * * cushion; * * * belt; qi and blood

Circulating machine; Foot bath tub; Plantar organs; Hand-held * * * device, * * * bathtub, fat belt;

Therapeutic instruments; Foot physiotherapy instrument; Weight loss belt; Car seat cushion; Kneading pad; * * * Chairman; Breast augmentation device;

Beauty equipment.

Family medical rehabilitation equipment, therapeutic instrument, Kang Kai high potential therapeutic instrument, cervical vertebra therapeutic instrument, domestic cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, functional chair, functional bed, supporter and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.

Home care equipment, home rehabilitation care auxiliary equipment, women's pregnancy and baby care products, home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box

Question 4: What kind of medical devices include: antipyretic stickers, bandages, photon cold glue, etc. According to the Regulation on the Supervision and Administration of Medical Devices, medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including the required computer software. Its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role; Its purpose is:

(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;

(3) Examination, substitution, adjustment or support of physiological structure or process;

(4) supporting or maintaining life;

(5) Pregnancy control;

(6) provide information for medical or diagnostic purposes by examining human samples.

Article 4 The State implements classified management of medical devices according to the degree of risk.

The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.

Question 5: What are the advantages of a class of medical devices? The first category of medical devices refers to medical devices that can ensure their safety and effectiveness through daily management.

In the classification catalogue of medical devices, there are the following categories of products in one category of medical devices.

Basic surgical instruments Microsurgical instruments

Neurosurgical instruments, ophthalmic surgical instruments

Otolaryngology surgical instruments stomatology surgical instruments

Thoracic cardiovascular surgical instruments, abdominal surgical instruments

Surgical instruments for urology, anorectal surgery and orthopedic surgery (plastic surgery)

Obstetrics and gynecology surgical instruments, family planning surgical instruments

Injection puncture instrument burn (plastic) surgical instrument

General diagnostic instruments, medical electronic instruments and equipment

Medical optical instruments, instruments and endoscopic equipment medical ultrasonic instruments and related equipment

Medical laser instruments and equipment medical high-frequency instruments and equipment

Physical therapy rehabilitation equipment traditional Chinese medicine equipment

Medical magnetic vibration equipment medical x-ray equipment

Medical x-ray accessory equipment and components medical high-energy x-ray equipment

Medical radionuclide equipment, medical radiation protection articles and devices

Clinical laboratory analytical instruments, medical laboratory tests and basic equipment and appliances

Extracorporeal circulation and blood treatment equipment, implant materials and artificial organs

Equipment and appliances for operating rooms, emergency rooms and clinics; Dental equipment and appliances.

Ward nursing equipment and appliances disinfection and sterilization equipment and appliances

Medical cold therapy, cryogenic and refrigeration equipment and appliances dental materials

Medical sanitary materials and dressings, medical suture materials and adhesives

Interventional equipment for medical polymer materials and products

The following products are all one kind of medical instruments: stethoscope, percussion hammer, reflector, vision diagnostic instrument, oral knife, chisel, oral forceps, corneal scissors, ophthalmic surgical scissors, micro-scissors, micro-gun-shaped surgical scissors, micro-tissue scissors, photo rack, sky rail rack, X-ray photo box, film developing rack and X-ray darkroom equipment.

Question 6: What are the first-class medical devices? Look up a category of medical devices.

Question 7: What kinds of medical devices are included? Medical devices that can ensure their safety and effectiveness through daily management. Such as most surgical instruments, stethoscopes, surgical caps, masks, medical X-rays, band-AIDS, etc.

Question 8: What are the first-class medical devices? 1. According to the Regulations on the Supervision and Administration of Medical Devices,

Article 4 The State implements classified management of medical devices according to the degree of risk.

The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.

Two, about soliciting opinions on the revision of the Category I Medical Device Catalogue (Draft for Comment) and some subdirectories of the Medical Device Classification Catalogue, please go to official website, China Food and Drug Administration to inquire about this article, which has an appendix.

Question 9: What kind of medical instruments are basically used in some hospitals, such as surgical instruments and suture materials, adhesives, artificial organs, etc.

Question 10: What kind of medical instruments include surgical instruments, stethoscopes, medical X-rays, medical X-ray protection devices, automatic electrophoresis apparatus, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, elastic bandages, polymer bandage, plasters, band-AIDS, cupping devices, surgical gowns, surgical caps, masks, urine collection bags, etc.