EU → North America Device Access

Ing. Carlo Alberto Issoglio & C. srl

IT-MF-000035570 · Italy · Omegna

Ing. Carlo Alberto Issoglio & C. srl is registered in the European database on medical devices as a manufacturer, with 2 700 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 061
Class IIb1 639

Among these devices, 895 are declared sterile, 1 639 implantable, 1 061 reusable.

Devices declared under this manufacturer

Showing 12 of 2 700 declared devices.

Catalogue references include W2-BOX03, W2-DC02, W2-FGBN3415S, W2-FGC35L, W2-FIS30, W2-FRBN38.

European nomenclature codes declared: L159099, P01020101, P01020180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 700
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 GTIN2 700
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. Ing. Carlo Alberto Issoglio & C. srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030149-01issued2030-09-10

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