EU → North America Device Access

ORTHOSOFT

FR-MF-000000216 · France · MAUGUIO

ORTHOSOFT is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa34

Most frequent device types declared: FLEXSOFT, FLEXSOFT DUO, GLENSOFT, IMMOSOFT, MANUSOFT.

Devices declared under this manufacturer

Showing 12 of 34 declared devices.

Catalogue references include FD11G, IM11D, IM12D, IM12G, ME11X, RH11D.

European nomenclature codes declared: Y060612, Y060606, Y060613, Y060615, Y062403, Y060609.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN34
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. ORTHOSOFT was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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