Medical device record number how to see one or two categories

There are three categories of medical devices - Class I, Class II, Class III, what is the difference between these three categories, do you know?

The risk classification of medical devices has a detailed division, in which a class of low-risk, class II for the medium risk, class III for high-risk. Let's take a look at these three categories in the end what is the difference!

A class of medical devices:

A class of medical devices with a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), gua sha board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags.

Class I medical devices, number: A mechanical preparation BBBBCCCC No.

A that is the location of the abbreviation, imported medical devices for the "country", domestic medical devices for the provincial administrative abbreviation plus the municipal administrative abbreviation, such as "Yue Sui" The company's name is "GZ", which means "Guangzhou City, Guangdong Province".

B is the filing year

C is the filing number

such as: National Instruments Preparation No. 20201234

Class II Medical Devices:

Class II has a moderate risk of needing to strictly control the management of medical devices to ensure their safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on. (The four meridian integrated intermediate frequency therapeutic instrument belongs to the second class)

Class III medical devices:

Class III has a higher risk, the need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound swelling liu focused knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters.

Class II and III medical devices, the number is: A mechanical note BCCCCCDEEFFFF

A represents the location of the abbreviation, imported medical devices for the "country", domestic medical devices for the provincial administrative regions.

B indicates the form of registration, imported "into", domestic "quasi", Hong Kong, Macao and Taiwan for the "permit".

C indicates the year of first registration

D indicates the management category, "2" for Class II medical devices, "3" for Class III medical devices

EE indicates the classification code, the specific classification code can be found in the General Administration of Pharmaceutical Supervision and Administration. The specific classification code can be viewed at the State Drug Administration.

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F first registration number.

e.g.: National Instruments Note into 20203401234