What is Medical Device Registration and Listing

Medical Device Registration and Listing

Registration: medical device manufacturers registered with FDA

Listing: medical devices listed with FDA

Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.

FDA Certification

Contact Us to learn more about FDA Certification for your medical devices, as well as 510k premarket submission, medical device registration and listing etc.

Sources

Establishment Registration & Device Listing Quick Search

Class I / II Exemptions 

Classify Your Medical Device