EU → US Device Access

AB Diagnostic Systems GmbH

DE-MF-000025407 · Germany · Berlin

AB Diagnostic Systems GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other10

Most frequent device types declared: DK.013.01.3, DK.003.01.3, DK.030.05.3, DK.029.01.3, DK.013.05.3.

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 EUDAMED10
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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