EU → North America Device Access

Radiobotics ApS

DK-MF-000023156 · Denmark · Copenhagen

Radiobotics ApS is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Among these devices, 1 are declared with a measuring function.

Devices declared under this manufacturer

Catalogue references include 2.2, 2.4, 3, 4, RBfracture, RBfracture 2.1.

European nomenclature codes declared: Z11030592, Z11030582.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. Radiobotics ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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