EU → North America Device Access

Somamed AS

NO-MF-000007511 · Norway · Nesoddtangen

Somamed AS is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa19

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include RHB3096, RHB3607, RHB4017, RHJ3645, RHR1078, RHR3256.

European nomenclature codes declared: Q030199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
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 GTIN19
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. Somamed AS was not found in either the U.S. or the Canadian register.

Other manufacturers in Norway

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