EU → US 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: Comfort sling, Universal sling, Carts, Spreader bar Luna IPX4, Weight scale.

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

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

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