EU → US Device Access

VITROMED GmbH

DE-MF-000005131 · Germany · Jena

VITROMED GmbH is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa76
other24
Class I6
Class IIb2

Among these devices, 107 are declared sterile.

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 entryVITROMED GmbH (DE) · FDA 3016126174
Devices in EUDAMED108
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
2270294CE01supplemented2029-12-01

Other manufacturers in Germany

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