EU → US Device Access

Erbe Vision GmbH

DE-MF-000010268 · Germany · Wurmlingen

Erbe Vision GmbH is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa40

Most frequent device types declared: Medical Monitor, VIRON 1 , Light source, Adaptor for endoscope sheaths, Fiberoptic cable.

Among these devices, 26 are declared reusable, 13 active.

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 EUDAMED40
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
D1192000031supplemented2028-05-21

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