EU → US Device Access

VOCO GmbH

DE-MF-000008601 · Germany · Cuxhaven

VOCO GmbH is registered in the European database on medical devices as a manufacturer, with 865 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa865

Most frequent device types declared: syringe, tube, single dose, posts, bottle.

Among these devices, 654 are declared implantable, 12 reusable, 9 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 entryVOCO GMBH (DE) · FDA 8010908
Devices in EUDAMED865
Country of registrationGermany

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