EU → US Device Access

RAUMEDIC AG

DE-MF-000006155 · Germany · Helmbrechts

RAUMEDIC AG is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa39

Among these devices, 1 are declared sterile, 2 with a measuring function.

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 registerSimilar name found — unverified
Matched entryRAUMEDIC - Muenchberg (DE) · FDA 3006946348
Devices in EUDAMED39
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Germany

All Germany manufacturers →