EU → North America Device Access

Synthon Hispania S.L.

ES-MF-000004771 · Spain · Sant Boi de Llobregat

Synthon Hispania S.L. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include Autoxon, Myject, Sensigo.

European nomenclature codes declared: A99.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySYNTHON HISPANIA S.L. (ES) · FDA 3004837462
Devices in EUDAMED7
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN7
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: United States only. Synthon Hispania S.L. is registered in the United States but was not found in the Canadian register.

Other manufacturers in Spain

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