EU → US Device Access

Malsch GmbH

DE-MF-000005173 · Germany · Wildeck Obersuhl

Malsch GmbH is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa26

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 entryMALSCH GMBH (DE) · FDA 3011670571
Devices in EUDAMED26
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →