EU → North America Device Access

Heyer Aerotech GmbH

DE-MF-000013791 · Germany · Nievern

Heyer Aerotech GmbH is registered in the European database on medical devices as a manufacturer, with 567 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa546
Class IIb21

Among these devices, 115 are declared active.

Devices declared under this manufacturer

Showing 12 of 567 declared devices.

Catalogue references include 00002385, 6600107-AGA, 6600118-3, 6600137-3-CH, 6600139-4, 6600185-3.

European nomenclature codes declared: Z120309.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED567
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 GTIN567
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. Heyer Aerotech GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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