EU → North America Device Access

Excellent Systems A/S

DK-MF-000014754 · Denmark · Mørke

Excellent Systems A/S is registered in the European database on medical devices as a manufacturer, with 283 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa283

Among these devices, 283 are declared active.

Devices declared under this manufacturer

Showing 12 of 283 declared devices.

Catalogue references include 12503-2, 12510-2, 12546-2, 18010-2, B12732-2, B14104-2.

European nomenclature codes declared: Y1899, Y183015, Y183015,Y1899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED283
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 GTIN283
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. Excellent Systems A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

All Denmark manufacturers →