EU → US Device Access

ADE Germany GmbH

DE-MF-000005406 · Germany · Hamburg

ADE Germany GmbH is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa43

Most frequent device types declared: M504xxx, M32xxxx, M118xxx, M404xxx, M4-Serie.

Among these devices, 43 are declared active, 43 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 entryADE GERMANY GMBH (DE) · FDA 3044853249
Devices in EUDAMED43
Country of registrationGermany

Other manufacturers in Germany

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