EU → North America Device Access

GIMA SPA

IT-MF-000011004 · Italy · MILANO

GIMA SPA is registered in the European database on medical devices as a manufacturer, with 793 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa793

Most frequent device types declared: CANNULA ASPIRAZIONE RIUTILIZZABILE, CAPPELLINI RIUTILIZZABILI, DUOFONO ADULTI, FONENDOSCOPIO, FONENDOSCOPIO ADULTI.

Among these devices, 51 are declared active.

Devices declared under this manufacturer

Showing 12 of 793 declared devices.

Catalogue references include 25623, 26311, 28260, 31310, 32539, 34129.

European nomenclature codes declared: V9099, C9005, V0402, L01040199, T0207, L0205.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED793
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN793
Found in the U.S. device database0
Share0.0 %

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. GIMA SPA was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT349382issued2031-01-26

Other manufacturers in Italy

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