EU → US Device Access

Roche Diabetes Care GmbH

DE-MF-000006276 · Germany · Mannheim

Roche Diabetes Care GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other8
Class IIb2

Most frequent device types declared: Model NC.

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 entryRoche Diabetes Care GmbH (DE) · FDA 3011806823
Devices in EUDAMED10
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →