EU → US 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: Pocket, MOD Home Edition - Cottonbal White, Plus 5 Minutes - White, MOD Tie Dye, Pocket - Turquoise Blue.

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED57
Country of registrationNetherlands
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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