EU → North America Device Access

Oxigen Salud, S.A.

ES-MF-000036693 · Spain · Sant Cugat del Vallès

Oxigen Salud, S.A. is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa25

Among these devices, 25 are declared active.

Devices declared under this manufacturer

Showing 12 of 25 declared devices.

Catalogue references include 8010049, 8010051, 8010052, 8010058, 8010081, 8010099.

European nomenclature codes declared: V0901, V0902.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED25
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN25
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. Oxigen Salud, S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

All Spain manufacturers →