EU → US Device Access

Eduard Gerlach GmbH

DE-MF-000006590 · Germany · Lübbecke

Eduard Gerlach GmbH is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa38

Most frequent device types declared: VHO-OSTHOLD-SCHLAUFE, VHO-OSTHOLD-Spange Mezzo 0,3 mm.

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 entryEduard Gerlach Gmbh (DE) · FDA 3004632523
Devices in EUDAMED38
Country of registrationGermany

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