EU → US Device Access

Wolff Kunststoffe GmbH

DE-MF-000017849 · Germany · Mörlenbach

Wolff Kunststoffe GmbH is registered in the European database on medical devices as a manufacturer, with 194 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa194

Most frequent device types declared: 1-Valve / 1-Chamber, 2-Valve / 2-Chamber, C4 / 1-or 4 chamber with central valve, 4 Valve / 4 Chamber, Accessories.

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 EUDAMED194
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

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