EU → North America Device Access

ICOGUANTI S.p.A.

IT-MF-000053804 · Italy · Milano

ICOGUANTI S.p.A. is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa95

Most frequent device types declared: Guanti monouso da esame in lattice con polvere, Guanti monouso da esame in lattice naturale senza polvere, Guanti monouso da esame in nitrile senza polvere, Guanto Medicale Monouso da Esame a base di Polivinyl cloruro, non ster.

Devices declared under this manufacturer

Showing 12 of 95 declared devices.

Catalogue references include EHP/S, EHRP/M, EMAG/M, ESB/XS, ESNL/XL, ESPF/L.

European nomenclature codes declared: T010201, T01020204, T01020201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED95
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 GTIN95
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. ICOGUANTI S.p.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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