EU → US Device Access

Novo Klinik-Service GmbH

DE-MF-000005289 · Germany · Bergheim

Novo Klinik-Service GmbH is registered in the European database on medical devices as a manufacturer, with 304 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa292
Class IIb12

Most frequent device types declared: Kanülenhalteband, Tubusfixierung, Pflasterfixierung, Hand- und Fußfixierung, Kabel-und Schlauchhalterung.

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 EUDAMED304
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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