EU → North America Device Access

Robo Educational Toys B.V.

NL-MF-000039458 · Netherlands · Vierpolders

Robo Educational Toys B.V. is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa57

Most frequent device types declared: JAC5800, MAX, MOD Home Edition - Cottonbal White, MOD Tie Dye, Plus 5 Minutes - White.

Among these devices, 56 are declared active, 24 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 57 declared devices.

Catalogue references include JAC5025, JAC5036, JAC5038, JAC5100, JAC5107, JAC5109GR.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED57
Country of registrationNetherlands

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

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. Robo Educational Toys B.V. was not found in either the U.S. or the Canadian register.

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