EU → North America Device Access

iVis Technologies S.r.l.

IT-MF-000016859 · Italy · Taranto

iVis Technologies S.r.l. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb11
Class IIa2

Most frequent device types declared: AA60, AX002, AX003, B60, CX001, DX001.

Among these devices, 5 are declared sterile, 3 implantable, 8 active, 3 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include AX002, AX003, B60, CX001, DX001, HX001, NX001.

European nomenclature codes declared: Z12011082, P030102090202, Q02030299, Z12120199, Z12011001, Z12120123.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryIVIS TECHNOLOGIES S.R.L.

North American profile: Canada only. iVis Technologies S.r.l. holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Italy

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