ZIACOM ITS S.r.l.
IT-MF-000028897 · Italy · Vigonza (PD)
ZIACOM ITS S.r.l. is registered in the European database on medical devices as a manufacturer, with 674 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 408 |
|---|---|
| Class IIa | 266 |
Most frequent device types declared: DENTAL IMPLANTS -BIPHASIC, DENTAL IMPLANTS -MONOPHASIC, Implant prosthetic components, Surgical accessories, Surgical instruments.
Among these devices, 144 are declared sterile, 408 implantable, 266 reusable.
Catalogue references include DR 8121, HAST 5231, K 600, KAC 5541, KASN 5260, KASN 5264.
European nomenclature codes declared: P01020180, P01020101, Z12110102, L159099, Q010207, Q010280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 674 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 674 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ZIACOM ITS S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030185-00 | issued | 2031-04-16 |