EU → US Device Access

a1 medical GmbH

DE-MF-000006489 · Germany · Tuttlingen

a1 medical GmbH is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa23

Among these devices, 23 are declared reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryA1 MEDICAL GMBH (DE) · FDA 3009504366
Devices in EUDAMED23
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →