EU → US Device Access

AGA Sanitätsartikel GmbH

DE-MF-000005876 · Germany · Löhne

AGA Sanitätsartikel GmbH is registered in the European database on medical devices as a manufacturer, with 388 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa388

Most frequent device types declared: H-GYMK 10100/Y 980, H-GYMK 20100/E, BOZ-1070/3NS, RP-1058/E, UUS-3058/E.

Among these devices, 1 are declared sterile, 71 active.

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 EUDAMED388
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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