EU → US Device Access

Black Forest Medical GmbH

DE-MF-000005752 · Germany · Freiburg im Breisgau

Black Forest Medical GmbH is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa138
Class I39

Among these devices, 9 are declared sterile, 43 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 entryBlack Forest Medical GmbH (DE) · FDA 3003923584
Devices in EUDAMED177
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
1000297665supplemented2028-07-05
1000297641supplemented2029-03-21

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