EU → US 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 220 MOUTHWASH 200ml_Central Europe, CURASEPT ADS DNA 0,12 COLLUTORIO 200 ml, CURASEPT ADS DNA 220 MOUTHWASH 200ml_Europe, CURASEPT ADS DNA 212 MOUTHWASH 200ml_Adriatic, CURASEPT ADS DNA 212 MOUTHWASH 200ml_Central Europe.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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