EU → North America Device Access

RESPINOR AS

NO-MF-000012955 · Norway · OSLO

RESPINOR AS 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, 4 are declared active, 2 with a measuring function.

Catalogue references include 970-0003, 970-0003 4.1, 980-0002, 990-0003, 990-0004.

European nomenclature codes declared: Z11049092, Z11049080, M04010202.

United States market access

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

⚠️ 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. RESPINOR AS was not found in either the U.S. or the Canadian register.

Other manufacturers in Norway

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