EU → US Device Access

A.M.I. Agency for Medical Innovations GmbH

AT-MF-000016792 · Austria · Feldkirch

A.M.I. Agency for Medical Innovations GmbH is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa23

Among these devices, 8 are declared sterile, 10 reusable, 2 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 registerRegistered with FDA
Matched entryA.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH (AT) · FDA 3005049530
Devices in EUDAMED23
Country of registrationAustria

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