EU → US Device Access

Wellgo Medical Products GmbH

DE-MF-000033132 · Germany · Wuppertal

Wellgo Medical Products GmbH is registered in the European database on medical devices as a manufacturer, with 499 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa481
Class IIb18

Most frequent device types declared: Disposable Needle Guide, Biopsy Needles, Bone Biopsy Needle, Coaxial Needle, Tumor Marker Needle w/Gold Marker.

Among these devices, 497 are declared sterile, 18 implantable, 2 reusable.

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 registerNot found in the FDA register
Devices in EUDAMED499
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Germany

All Germany manufacturers →