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: Implant prosthetic components, Surgical instruments, Surgical accessories, DENTAL IMPLANTS -BIPHASIC, DENTAL IMPLANTS -MONOPHASIC.
Among these devices, 144 are declared sterile, 408 implantable, 266 reusable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 674 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030185-00 | issued | 2031-04-16 |