EU → US Device Access

audifon GmbH & Co. KG

DE-MF-000008355 · Germany · Kölleda

audifon GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 443 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa443

Most frequent device types declared: Hearing aid, Receiver unit, Dome, Noiser, Sound tube.

Among these devices, 349 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 registerRegistered with FDA
Matched entryAUDIFON - GMBH & CO.KG (DE) · FDA 3006076696
Devices in EUDAMED443
Country of registrationGermany

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