EU → US Device Access

Bernhard Förster GmbH

DE-MF-000006256 · Germany · Pforzheim

Bernhard Förster GmbH is registered in the European database on medical devices as a manufacturer, with 15 150 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15 134
Class IIb16

Among these devices, 16 are declared implantable.

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 registerNot found in the FDA register
Devices in EUDAMED15 150
Country of registrationGermany
⚠️ 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
1000297994issued2029-04-18
1000244470issued2030-06-05

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