EU → North America Device Access

CANÈ S.p.A.

IT-MF-000013520 · Italy · Rivoli (TO)

CANÈ S.p.A. is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb26
Class IIa7

Most frequent device types declared: CRONOBELL ADAPTER, CRONOFILL, CRONOJET, FRM pumps, INF pumps.

Among these devices, 2 are declared sterile, 29 active, 28 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 33 declared devices.

Catalogue references include CCSFLL, CCSJT1, PS3DL, PS3FL, PS3LL, PS3OL.

European nomenclature codes declared: Z12030302, A0280, Z12030399, A020102020102, A02010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
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 GTIN33
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. CANÈ S.p.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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