EU → North America Device Access

Curasept S.p.A

IT-MF-000009299 · Italy · Saronno

Curasept S.p.A is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I9

Most frequent device types declared: CURASEPT ADS DNA 0,12 COLLUTORIO 200 ml, CURASEPT ADS DNA 0,20 COLLUTORIO 200 ml, CURASEPT ADS DNA 212 MOUTHWASH 200ml_Adriatic, CURASEPT ADS DNA 212 MOUTHWASH 200ml_Central Europe, CURASEPT ADS DNA 212 MOUTHWASH 200ml_Europe.

Devices declared under this manufacturer

Catalogue references include CS-02169, CS-02170, CS-02224, CS-02225, CS-02235, CS-02236.

European nomenclature codes declared: Q019007.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN9
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. Curasept S.p.A was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →