EU → North America Device Access

Copan Italia S.P.A.

IT-MF-000022535 · Italy · Brescia

Copan Italia S.P.A. is registered in the European database on medical devices as a manufacturer, with 228 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa63

Among these devices, 128 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 228 declared devices.

Catalogue references include 155C, 220526, 355C, 3U090N, 477CE.A, 606CS01M.

European nomenclature codes declared: W050301020101, W05030302, A1101, A1102, W050301020102, W05039099.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryCOPAN ITALIA (IT) · FDA 3002444944
Devices in EUDAMED228
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN201
Found in the U.S. device database80
Share39.8 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCOPAN ITALIA S.P.A.

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices5
First licensed2003-03-25

Licence types: Device Family (5).

Licensed under: ADVANCE SWAB TRANSPORT SYSTEM FOR MICROBIOLOGY, ADVANCED SWAB TRANSPORT SYSTEM FOR MICROBIOLOG, VAGINAL SELF-SAMPLING FLOQSWABS, PRESERVATION MEDIUM FOR NUCLEIC ACIDS, FLOQSWABS.

Notified body certificates

CertificateStatusExpiry
V11 073936 0015issued2027-04-18
G10 073936 0018issued2028-02-12

Other manufacturers in Italy

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