EU → US Device Access

SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUT ICA ED AFFINI

IT-MF-000042328 · Italy · Pomezia

SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUT ICA ED AFFINI is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24
Class IIb4

Most frequent device types declared: Eva/Qu Adulti 6 supposte, Eva/Qu Bambini 6 supposte, Eva/Qu saggio, Psoril, No Reflus.

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 EUDAMED28
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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