EU → North America 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, 1233.083, 1261.208, 157.152, 157.352.

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

Devices declared under this manufacturer

Showing 12 of 382 declared devices.

Catalogue references include 1231.123, 1233.083, 1261.208, 157.352, 6261.20, 8128.620.

European nomenclature codes declared: C01020203, C01020101, C01020202, C0101010102, C010280, C01020201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVYGON Germany GmbH (DE) · FDA 9612433
Devices in EUDAMED382
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN382
Found in the U.S. device database13
Share3.4 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. VYGON Germany GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →