Zirkonzahn SRL
IT-MF-000028795 · Italy · Gais (BZ)
Zirkonzahn SRL is registered in the European database on medical devices as a manufacturer, with 480 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 401 |
|---|---|
| Class IIb | 79 |
Among these devices, 373 are declared implantable, 8 active, 8 with a measuring function.
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 | Registered with FDA |
|---|---|
| Matched entry | ZIRKONZAHN SRL (IT) · FDA 3005904906 |
| Devices in EUDAMED | 480 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
207/MDR | supplemented | 2030-03-24 |