EU → North America Device Access

DecoCare

NL-MF-000015695 · Netherlands · Tilburg

DecoCare is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa32

Most frequent device types declared: 2365 (75 x 48 x 2-10 cm), 3002 (100 x 150 cm), 3016R, 3170, 3171.

Devices declared under this manufacturer

Showing 12 of 32 declared devices.

Catalogue references include 2326, 2365, 3001, 3002, 3011G, 3015G.

European nomenclature codes declared: V080505, V9099, T0499, Z12019010, T04010202, V0811.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED32
Country of registrationNetherlands

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN32
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. DecoCare was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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