EU → North America Device Access

Reskin Medical NV

BE-MF-000012226 · Belgium · Tessenderlo

Reskin Medical NV is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Silicone adherent fixation tape, Silicone based Wound dressing.

Among these devices, 6 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 72642, 72643, SF-1012, SF-1520, SPNS1830, SPYSIL-253000.

European nomenclature codes declared: M04040601, M04040701, H900299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN16
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. Reskin Medical NV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

All Belgium manufacturers →