EU → US Device Access

VYGON Germany GmbH

DE-MF-000005305 · Germany · Aachen

VYGON Germany GmbH is registered in the European database on medical devices as a manufacturer, with 382 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa305
Class I77

Most frequent device types declared: 1231.123, 8159.125, 8157.372, 8128.620, 1233.083.

Among these devices, 380 are declared sterile, 71 implantable.

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 entryVYGON Germany GmbH (DE) · FDA 9612433
Devices in EUDAMED382
Country of registrationGermany

Other manufacturers in Germany

All Germany manufacturers →