EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 649 declared devices.

Catalogue references include 1095.18, 1245.14, 1250.18, 2370.24, 2526.18, 2716.

European nomenclature codes declared: U020302, U010201, U040199, U01010501, U040203, U090101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED649
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN649
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. UROMED Kurt Drews KG was not found in either the U.S. or the Canadian register.

Notified body certificates

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

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