EU → North America Device Access

Furine ApS

DK-MF-000001231 · Denmark · Skævinge

Furine ApS is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa124

Devices declared under this manufacturer

Showing 12 of 124 declared devices.

Catalogue references include A00NO11, B05CH22, B05DE22, B06SE22, B10CH10, B10TR10.

European nomenclature codes declared: A060399, A108005, A108004.

United States market access

FDA establishment registerRegistered with FDA
Matched entryFURINE APS (DK) · FDA 3030398124
Devices in EUDAMED124
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN124
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: United States only. Furine ApS is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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