EU → US Device Access

Zimmer MedizinSysteme GmbH

DE-MF-000006141 · Germany · Neu-Ulm

Zimmer MedizinSysteme GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa10

Most frequent device types declared: Soleoline, PhySys, CardioAirPlus, CardioPortFour, CardioPortFour BT.

Among these devices, 10 are declared active, 4 with a measuring function.

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 entryZIMMER MEDIZINSYSTEME GMBH (DE) · FDA 8010720
Devices in EUDAMED10
Country of registrationGermany

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