EU → US Device Access

X-CEN-TEK GmbH & Co.KG

DE-MF-000009521 · Germany · Wardenburg

X-CEN-TEK GmbH & Co.KG is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa28

Among these devices, 22 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 entryX-CEN-TEK GmbH & Co. KG (DE) · FDA 3011650322
Devices in EUDAMED28
Country of registrationGermany

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