EU → North America Device Access

Innov'SA

FR-MF-000006814 · France · Bar Sur Seine

Innov'SA is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include EDE2_BLOC, EDE2_CHCO, EDE2_GALE, EDE2_GRCH, EDE2_GRGA, EDE2_SAPH.

European nomenclature codes declared: Y122103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. Innov'SA was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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