EU → US Device Access

synedra information technologies GmbH

AT-MF-000000903 · Austria · Innsbruck

synedra information technologies GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5

Among these devices, 5 are declared 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 EUDAMED5
Country of registrationAustria
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
170780826withdrawn2026-12-15
1000186556supplemented2026-12-01

Other manufacturers in Austria

All Austria manufacturers →