EU → US Device Access

S.A.M. s.r.l.

IT-MF-000035723 · Italy · BARGHE

S.A.M. s.r.l. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: LRG30SC, I01 Ghiaccio istantaneo PE, MED26ST, SML20SC, SML20ST.

Among these devices, 8 are declared sterile, 2 active.

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 EUDAMED10
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.

Other manufacturers in Italy

All Italy manufacturers →