EU → North America Device Access

Nordic Sense A/S

DK-MF-000042394 · Denmark · Silkeborg

Nordic Sense A/S is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Devices declared under this manufacturer

Catalogue references include 00034100/ 10101458, 00065140-1/10101554, 00086378/10101673, 00086379/10101673, 00090172-1/10101555, 00090172/10101555.

European nomenclature codes declared: Z1399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationDenmark

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

Device-level evidence

Devices with a numeric GTIN10
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. Nordic Sense A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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