EU → US Device Access

Plusoptix GmbH

DE-MF-000006138 · Germany · Nürnberg

Plusoptix GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: A12C, A12R, S12C, S12R, S16, A16, S20, A20.

Among these devices, 8 are declared active, 8 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 entryPLUSOPTIX GMBH (DE) · FDA 3003829667
Devices in EUDAMED8
Country of registrationGermany

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