EU → North America Device Access

T-Systems Austria GesmbH

AT-MF-000000388 · Austria · Vienna

T-Systems Austria GesmbH 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 IIa5

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 10.3.0.0, 10.4.0.0, 11.7.0, 11.8.0, 912010802RCN4.

European nomenclature codes declared: V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationAustria

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. T-Systems Austria GesmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

All Austria manufacturers →