EU → US Device Access

Ear-Technic GmbH

DE-MF-000043916 · Germany · Bremen

Ear-Technic GmbH is registered in the European database on medical devices as a manufacturer, with 226 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa226

Most frequent device types declared: ITEKIT Hearing Aids Series, BTE Hearing Aids Series, ITE Hearing Aids Series, TIE Hearing Aids Series.

Among these devices, 226 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 EUDAMED226
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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