EU → North America Device Access

VitalAire GmbH

DE-MF-000005323 · Germany · Norderstedt

VitalAire GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: GSAFE 2018, GSAFE 2025, GSAFE1915, GSAFE1918, GSAFE1920.

Among these devices, 8 are declared sterile.

Devices declared under this manufacturer

Catalogue references include GSAFE1915, GSAFE1918, GSAFE1920, GSAFE1925, GSAFE2015, GSAFE2018.

European nomenclature codes declared: A01010301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN8
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. VitalAire GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →