EU → North America Device Access

Osteophoenix SL

ES-MF-000004171 · Spain · Bilbao

Osteophoenix SL is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb18

Most frequent device types declared: CH03, FM2535, FS1825, P0104, P0106.

Among these devices, 18 are declared implantable.

Catalogue references include CH03, FM2535, FS1825, P0104, P0106, T1507.

European nomenclature codes declared: P09120604, P09120599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN18
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. Osteophoenix SL was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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