EU → North America Device Access

MOBILE-TECHNICS BV

BE-MF-000037911 · Belgium · Putte

MOBILE-TECHNICS BV is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: TRI BIKE BAMBI.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include TRI BIKE CLASSIC S, TRI BIKE CLASSIC S24, TRI BIKE CLASSIC Y, TRI BIKE CLASSIC Y COMFORT, TRI BIKE E-CLASSIC S24, TRI BIKE E-CLASSIC Y.

European nomenclature codes declared: Y99.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
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 GTIN21
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. MOBILE-TECHNICS BV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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