EU → US Device Access

CODAN Medizinische Geräte GmbH

DE-MF-000005286 · Germany · Lensahn

CODAN Medizinische Geräte GmbH is registered in the European database on medical devices as a manufacturer, with 573 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa573

Most frequent device types declared: INF1-P-EO, INF2-P-EO, INF4-G-EO, TRANS1-P-EO, INF5-G-EO.

Among these devices, 573 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 registerNot found in the FDA register
Devices in EUDAMED573
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
G10 010393 0534issued2027-02-16

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