EU → North America Device Access

KARTSANA, S.L.

ES-MF-000038368 · Spain · Sant Quirze del Vallès

KARTSANA, S.L. is registered in the European database on medical devices as a manufacturer, with 129 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa129

Most frequent device types declared: MTR-120, R-1002A, R-1002C, R-419L, S-127B.

Among these devices, 50 are declared active.

Devices declared under this manufacturer

Showing 12 of 129 declared devices.

Catalogue references include MTR-120, R-1002A, R-1002C, S-127B, TG-1000-P, TG-2022-P.

European nomenclature codes declared: V08050101, V08050102, V0805038001, V080502, V0880.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED129
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 GTIN129
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. KARTSANA, S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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