EU → US Device Access

DETAX GmbH

DE-MF-000022666 · Germany · Ettlingen

DETAX GmbH is registered in the European database on medical devices as a manufacturer, with 267 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa267

Most frequent device types declared: Colour variants, Dental Restoration Material, Colour Variants, Lacquers for earmolds, Colour variants, different Brand names.

Among these devices, 36 are declared implantable.

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 entryDETAX GMBH (DE) · FDA 9680954
Devices in EUDAMED267
Country of registrationGermany

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