EU → North America Device Access

X-os S.A.

CH-MF-000020666 · Switzerland · Lugano

X-os S.A. is registered in the European database on medical devices as a manufacturer, with 115 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb114
Class IIa1

Most frequent device types declared: GF2, GT2, Guichet Screw GSC, Guichet V2 Femur.

Among these devices, 94 are declared sterile, 115 implantable.

Authorised representative in the Union: SAS Isocèle Conseil.

Devices declared under this manufacturer

Showing 12 of 115 declared devices.

Catalogue references include GF21126, GF21128NS, GF21226, GF21426, GSC3560, GSC3562.

European nomenclature codes declared: P09120604.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED115
Country of registrationSwitzerland

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

Device-level evidence

Devices with a numeric GTIN115
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. X-os S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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