EU → North America Device Access

IMS GIOTTO S.p.A.

IT-MF-000025920 · Italy · Sasso Marconi (BO)

IMS GIOTTO S.p.A. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13

Most frequent device types declared: FLEXICHAIR, G-VIEW, GALILEO, MAMMOBED, RWS.

Among these devices, 13 are declared active.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 28300, 31002, 31012, 31020, 31079, 31080.

European nomenclature codes declared: Z11069005, W05019099, Z11069092, V08020199, V08060199, Z11030292.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIMS GIOTTO S.p.A. (IT) · FDA 9680027
Devices in EUDAMED17
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database1
Share5.9 %

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. IMS GIOTTO S.p.A. is registered in the United States but was not found in the Canadian register.

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