EU → North America Device Access

Spes Medica S.p.A.

IT-MF-000008858 · Italy · Genova

Spes Medica S.p.A. is registered in the European database on medical devices as a manufacturer, with 847 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa847

Among these devices, 403 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 847 declared devices.

Catalogue references include 1003CROC71F, D00000MA000, DENIGL15026, EMELG12026, GDRG002526, LEAD102644.

European nomenclature codes declared: N01010299, N010101, N010199, C020501, N01010203, N010201.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySPES MEDICA S.P.A (IT) · FDA 3005581220
Devices in EUDAMED847
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN847
Found in the U.S. device database157
Share18.5 %

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

Other manufacturers in Italy

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