EU → North America Device Access

Klinika Medical GmbH

DE-MF-000009433 · Germany · Usingen

Klinika Medical GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb2
Class IIa4

Among these devices, 6 are declared sterile, 2 implantable.

Devices declared under this manufacturer

Catalogue references include 105880900N, 2001105, 2001155, 2001205, 2001255, 205880900C.

European nomenclature codes declared: V0402, V9099, A019012, W05020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryKLINIKA MEDICAL GMBH (DE) · FDA 3008352701
Devices in EUDAMED6
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN6
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: United States only. Klinika Medical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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