EU → North America Device Access

Remecure ApS

DK-MF-000039260 · Denmark · Holte

Remecure ApS is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: C section 2 sheets,C section 1 sheet ,Tummy Tuck ,Augmaplexy ,Acne/Fac.

Devices declared under this manufacturer

Catalogue references include 1719, 1726, 1733, 1740, 1757, 1764.

European nomenclature codes declared: M04040702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Remecure ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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