The registration number of medical devices can be found in the US Food and Drug Administration.
The Medical Device Registration Certificate is uniformly printed by the State Food and Drug Administration of the United States, and the corresponding contents are filled in by the (food) drug supervision and administration department that approved the registration. (August 9, 2004 to present)
The arrangement of registration numbers begins with the following contents:
* (*)1(food) medical instrument (* 2) No.3. ××××××× 5×××××× 6, in which:
× 1 is the abbreviation of the location of the registration examination and approval department:
Class III medical devices in China, overseas medical devices and medical devices from Taiwan Province, Hongkong and Macau are designated as "China";
The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the central government where the registration examination and approval departments are located;
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 registration examination and approval department is located, plus the abbreviation of the municipal administrative region, which is ×× 1 (if there is no corresponding municipal administrative region with districts, it is only the abbreviation of the province, autonomous region and municipality directly under the central government);
×2 is the registration form (approval, entry and permission):
The word "quasi" is suitable for domestic medical devices;
The word "gold" is applicable to overseas medical devices;
The word "Xu" is applicable to medical devices in Taiwan Province Province, Hongkong and Macau.
××××× 3 is the year of registration approval;
×4 is the product management category;
××5 is the product variety code; (54- Operating room, emergency room, clinic equipment and appliances; 64- Medical and Health Materials and Dressings)
××××× 6 is the registration serial number.