EU → North America Device Access

A.M.I. Italia s.r.l.

IT-MF-000016770 · Italy · Napoli

A.M.I. Italia s.r.l. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb16
Class IIa1

Most frequent device types declared: GeoSaver P Dual mode 200J, GeoSaver P Dual mode 360J, GeoSaver semiautomatico 200J, SaverOne D S1 semiautomatico 200J, SaverOne D semiautomatico 200J.

Among these devices, 16 are declared active, 17 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include S1B-B0980, S1B-B0981, SGP-B0995, SGS-B0988, SMT-C14034, SVD-B0004.

European nomenclature codes declared: Z12030501, Z12030503, Z12030580.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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. A.M.I. Italia s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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