EU → US Device Access

UROMED Kurt Drews KG

DE-MF-000006084 · Germany · Oststeinbek

UROMED Kurt Drews KG is registered in the European database on medical devices as a manufacturer, with 649 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb354
Class IIa295

Among these devices, 623 are declared sterile, 181 implantable, 8 active, 8 with a measuring function.

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 EUDAMED649
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
20561GB450250724issued2030-07-23
1202GB448260427amended2031-03-12

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