EU → North America Device Access

Winncare Nordic

DK-MF-000002147 · Denmark · Korsør

Winncare Nordic is registered in the European database on medical devices as a manufacturer, with 362 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa362

Most frequent device types declared: Carts, Chargers and accessories, Comfort sling, Delta, Handcontrol for Luna.

Among these devices, 70 are declared active, 17 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 362 declared devices.

Catalogue references include 009-09766, 010-01413, 015-02108, 016-02136, 017-00330, 017-00354.

European nomenclature codes declared: V08050399, V0805038002, V080505, V030210, V08050302, V0805030102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryWinncare Nordic ApS (DK) · FDA 3004648937
Devices in EUDAMED362
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN362
Found in the U.S. device database8
Share2.2 %

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. Winncare Nordic is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

All Denmark manufacturers →