EU → North America Device Access

WUNDER SA.BI. S.R.L.

IT-MF-000028482 · Italy · BERGAMO

WUNDER SA.BI. S.R.L. is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa92

Among these devices, 86 are declared active, 92 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 92 declared devices.

Catalogue references include 00011A, 000482C+00060M, 000482IA+00060HM, 00090G, 00091DB, 00092D.

European nomenclature codes declared: V030210, Z12080402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED92
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 GTIN92
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. WUNDER SA.BI. S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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