□ (Food) Drug Supervision Measures (□) word □□□□ No. □ □ □ □ □ □ □□□□ No.
1 2 3 4 5 6
Specific meanings are as follows:
1 for the abbreviation of the location of the department for the approval of the registration: the territory of the third class of medical devices, medical devices outside the country, as well as in Taiwan, Hong Kong, Macao Medical devices for the "country"; within the second class of medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government for the abbreviation; within the first class of medical devices for the registration and approval of the department of the province, autonomous region, municipality directly under the Central Government for the abbreviation of the municipal administrative region of the city plus the abbreviation of the district (without the corresponding municipal administrative region of the city, the province, Autonomous regions, municipalities directly under the Central Government for short).
2 for the form of registration, including "quasi, into the permit",
"Quasi" word applies to the domestic medical devices;
"Into" word applies to foreign medical devices;
"Into" word applies to foreign medical devices;
"Into" word applies to foreign medical devices.
"Permit" applies to medical devices within the country;
"Import" applies to medical devices outside the country;
"Permit" applies to medical devices in Taiwan, Hong Kong and Macao.
3 for the approval of the year of registration.
4 is the product management category.
5 is the product variety code, the last two of the medical device classification code.
6 is the registration number.
If it is found that the registration number of the medical device purchased, sold or used is organized in a way that does not correspond to the above, the product is suspicious and the drug regulatory authority can be contacted.
Example: State Food and Drug Administration Measures (Quasi) Word 2007 No. 3400847
Meaning: the territory of the third class of medical devices, approved for registration in 2007, classified as 6840 Clinical Laboratory Analyzers, registration water number 0847.