EU → US Device Access

HILOTHERM GmbH

DE-MF-000006176 · Germany · Eisenharz

HILOTHERM GmbH is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa80

Most frequent device types declared: Hilotherapy Device HT02 , Hilotherapy Device HTP1 Pro.

Among these devices, 8 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 entryHILOTHERM GMBH (DE) · FDA 3011853381
Devices in EUDAMED80
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →