EU → North America Device Access

rdgKompagne

NL-MF-000041828 · Netherlands · Enschede

rdgKompagne is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa47

Devices declared under this manufacturer

Showing 12 of 47 declared devices.

Catalogue references include ELEK-MAATW, OPB-ARM-LOC, OPB-BEAD-T100, OPB-ELEK-LI, OPB-MODU-DD, OPB-WERKB-HI.

European nomenclature codes declared: Y122499, Y214299, Y214209, Y241203, Y240999, Y0599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED47
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 GTIN47
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. rdgKompagne was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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