EU → US Device Access

Genedrive Diagnostics Ltd.

GB-MF-000012810 · United Kingdom · Manchester

Genedrive Diagnostics Ltd. is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other38

Authorised representative in the Union: MT-AR-000000234.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED38
Country of registrationUnited Kingdom
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
ITDA/00006/0v003amended2030-05-27
IQMS/00016/0v001issued2030-05-27

Other manufacturers in United Kingdom

All United Kingdom manufacturers →