EU → US Device Access

Amann Girrbach AG

AT-MF-000000252 · Austria · Mäder

Amann Girrbach AG is registered in the European database on medical devices as a manufacturer, with 810 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa810

Among these devices, 777 are declared implantable.

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 entryAmann Girrbach AG (AT) · FDA 3030515618
Devices in EUDAMED810
Country of registrationAustria

Notified body certificates

CertificateStatusExpiry
G15 019612 0085 Rev. 00issued2031-06-07
G10 019612 0068issued2026-06-07

Other manufacturers in Austria

All Austria manufacturers →