EU → US 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.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED567
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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