EU → US Device Access

MK-dent GmbH

DE-MF-000010007 · Germany · Bargteheide

MK-dent GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: HE21KL.

Among these devices, 2 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 entryMK-dent GmbH (DE) · FDA 3003114027
Devices in EUDAMED5
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →