EU → North America Device Access

DUELEGS SRL

IT-MF-000050086 · Italy · GUIDIZZOLO

DUELEGS SRL is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa29

Catalogue references include 4627334, 4627342, DSABTM024, DSGBTM024.

European nomenclature codes declared: M030405.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED29
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 GTIN29
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. DUELEGS SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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