EU → North America Device Access

3S ORTHO

FR-MF-000002212 · France · Lyon

3S ORTHO is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I3
Class IIb3

Among these devices, 6 are declared sterile, 6 implantable.

Devices declared under this manufacturer

Catalogue references include EAI 0C07, EAI 0C08, EAI 0C10, IPP001, IPP3514, IPP4018.

European nomenclature codes declared: P0901040201, P090403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
Country of registrationFrance

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

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entry3S ORTHO

North American profile: Canada only. 3S ORTHO holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in France

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