EU → North America Device Access

NOXERIOR SRL

IT-MF-000029028 · Italy · GROSSETO

NOXERIOR SRL is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb12

Most frequent device types declared: PSA OXYGEN CONCENTRATOR - OXYSWING® OS Range - Master Unit, PSA OXYGEN CONCENTRATOR - OXYSWING® OS Range - Slave Unit.

Among these devices, 12 are declared active.

Devices declared under this manufacturer

Catalogue references include 04.901.008, 04.901.016, 04.901.024, 04.901.040, 04.901.048, 04.902.008.

European nomenclature codes declared: Z12159004.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationItaly

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

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. NOXERIOR SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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