EU → North America Device Access

ORTHOPLUS

FR-MF-000007297 · France · IGNY

ORTHOPLUS is registered in the European database on medical devices as a manufacturer, with 134 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa134

Most frequent device types declared: EF LINE, PREPOPlus®.

Devices declared under this manufacturer

Showing 12 of 134 declared devices.

Catalogue references include D590 001R, D590 006B, D590 300B, D590 300LK, D599 000P, PRACQ Q50.

European nomenclature codes declared: Q010499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED134
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 GTIN134
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. ORTHOPLUS was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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