EU → North America Device Access

Care Design I/S

DK-MF-000004848 · Denmark · Svendborg

Care Design I/S is registered in the European database on medical devices as a manufacturer, with 725 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa725

Most frequent device types declared: BedCoverPro. Pillow protector, junior, Bodystocking for adults, Bodystocking for adults., Bodystocking with probe opening, Bodysuit with shoulder straps and snap fasteners at the crotch..

Devices declared under this manufacturer

Showing 12 of 725 declared devices.

Catalogue references include 1200-Sort-168 (Børnestørrelse), 1200-Sort-XS, 1202-Bordeaux-152 (Børnestørrelse), 1203-Med lange ærmer-140-Bordeaux, 1206-Hvid-XL, 1210.1-Hvid-XXL.

European nomenclature codes declared: Y090399, Y0999.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED725
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 GTIN725
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. Care Design I/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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