EU → North America 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: I01 Ghiaccio istantaneo PE, I02 Ghiaccio istantaneo TNT, LRG30SC, LRG30ST, MED26SC.

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

Devices declared under this manufacturer

Catalogue references include I01, I02, LRG30SC, LRG30ST, MED26ST, SML20SC.

European nomenclature codes declared: U089006, M9001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationItaly

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

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. S.A.M. s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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