EU → North America Device Access

Kimetec GmbH

DE-MF-000006493 · Germany · Ditzingen

Kimetec GmbH is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa124

Most frequent device types declared: CBC Penlight LED, Cherry-shaped, M (22 mm), Cherry-shaped, S (18 mm).

Among these devices, 17 are declared active.

Devices declared under this manufacturer

Showing 12 of 124 declared devices.

Catalogue references include 2260, 2260K06, 2261K04, 500160, 500188, 521002001 (Kunden-REF 856096).

European nomenclature codes declared: V9003, L160101, Z129004, Z12080199, V020301, V020380,Z12080399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryKIMETEC GMBH (DE) · FDA 3000958046
Devices in EUDAMED124
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN124
Found in the U.S. device database2
Share1.6 %

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. Kimetec GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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