How to distinguish the approval number of one type of medical device from other types of medical devices?

The approval number of a class of medical devices is special, as follows:

× 1 mechanical equipment××××××× 2××××× 3.

These include:

X1is the abbreviation of the location of the filing department;

The first category of imported medical devices is the word "country";

The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the filing department is located plus the abbreviation of the municipal administrative region (there is no corresponding municipal administrative region with districts, but only the abbreviation of the province, autonomous region and municipality directly under the central government);

××××2 is the year of filing;

×××××× 3 is the serial number for filing.

The first category of medical devices refers to medical devices that can ensure their safety and effectiveness through routine management.

The rest are all other kinds of medical devices.

Classification of medical devices

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.

Extended data:

Commonly used drugs and medical devices

Family health care equipment: pain massage equipment, self-inspection equipment for family health care, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene products and family first aid supplies;

Family health massage products: electric massage chair/bed; Massage stick; Massage hammer; Massage pillow; Massage cushion; Massage belt; Qi-blood circulation machine; Foot bath tub; Foot massager; Hand-held massager, jacuzzi, fat throwing belt; Therapeutic instruments; Foot physiotherapy instrument; Weight loss belt; Car seat cushion; Kneading pad; Massage chair; Breast augmentation device; Beauty massager;

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

Home care equipment: home rehabilitation nursing AIDS, women's pregnant and baby care products, and home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed.

Commonly used medical instruments in hospitals: trauma treatment vehicles, operating tables, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, enzyme-labeled instruments, cleaning machines, urine analyzers, ultrasonic instruments (color ultrasound, B ultrasound, etc. ), X-ray machine, nuclear magnetic resonance, etc.

New medical equipment

With the development of science and technology, the scientific and technological achievements of some colleges and universities are also rapidly transformed into achievements. There are also some patented products produced by new manufacturers in the market, including some commonly used equipment in families and hospitals, such as medical trauma disposal vehicles.

References:

Baidu encyclopedia-medical equipment