EU → North America Device Access

CORMAN S.p.A.

IT-MF-000012539 · Italy · Lacchiarella

CORMAN S.p.A. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Assorbenti per perdite urinarie.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include COOPLINC04, COTLINC04, ORGINC01-RO, ORGUND01-RO, ORGUND02-RO, ORGUND04-RO.

European nomenclature codes declared: T04010102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
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 GTIN22
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCORMAN S.P.A.

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2020-06-24

Licence types: Device Family (3).

Licensed under: ORGANYC TAMPONS WITH CARDBOARD APPLICATOR, ORGANYC TAMPONS WITH ECO-APPLICATOR, ORGANYC TAMPONS WITH NO-APPLICATOR.

North American profile: Canada only. CORMAN S.p.A. holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Italy

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