EU → US Device Access

endocon GmbH

DE-MF-000020703 · Germany · Wiesenbach

endocon GmbH is registered in the European database on medical devices as a manufacturer, with 175 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa175

Most frequent device types declared: Arthroplasty revision system, chisel system for prosthesis removal.

Among these devices, 175 are declared reusable, 38 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 entryENDOCON GMBH (DE) · FDA 3042243169
Devices in EUDAMED175
Country of registrationGermany

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