EU → North America Device Access

DiaSorin Italia S.p.A.

IT-MF-000029422 · Italy · Saluggia

DiaSorin Italia S.p.A. is registered in the European database on medical devices as a manufacturer, with 151 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 151 declared devices.

Catalogue references include 310171, 310370, 310380, 310731, 311321, 314501.

European nomenclature codes declared: W0105080804, W0105080801, W0102152005, W0102152008, W0102152002, W0105080802.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDiaSorin Italia S.p.A. (IT) · FDA 9610240
Devices in EUDAMED151
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN151
Found in the U.S. device database18
Share11.9 %

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: United States only. DiaSorin Italia S.p.A. is registered in the United States but was not found in the Canadian register.

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