EU → North America Device Access

Humanchemie GmbH

DE-MF-000005661 · Germany · Alfeld (Leine)

Humanchemie GmbH is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa29

Among these devices, 8 are declared implantable, 7 active.

Devices declared under this manufacturer

Showing 12 of 29 declared devices.

Catalogue references include 08, 14, 15, 16, 17, 20.

European nomenclature codes declared: Q0199, Q010199, Q01010199, Q01010199,Q01010399, Q01010202, Q01010399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED29
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 GTIN29
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. Humanchemie GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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