EU → North America Device Access

G.COMM S.R.L.

IT-MF-000026843 · Italy · SULBIATE

G.COMM S.R.L. is registered in the European database on medical devices as a manufacturer, with 77 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa77

Most frequent device types declared: BRACCIO LAMPADA IN ACCIAIO, BRACCIO LAMPADA IN ALLUMINIO, COREWHITE, IRIS, IRIS VIEW.

Among these devices, 33 are declared active.

Catalogue references include 86.M400.0000, 86.M500.0000, 86060000, 86190000/F, 86390000, 86401000.

European nomenclature codes declared: Z12110180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED77
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 GTIN77
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. G.COMM S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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