Fin-ceramica faenza spa
IT-MF-000023496 · Italy · Faenza
Fin-ceramica faenza spa is registered in the European database on medical devices as a manufacturer, with 110 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 110 |
|---|
Most frequent device types declared: 01600288, 01600401, 01600406, 01600815, MaioRegen.
Among these devices, 110 are declared sterile, 110 implantable.
Devices declared under this manufacturer
- ENGIpore Ortho
- MaioRegen Chondro+
- MaioRegen Chondro+ Oval
- MaioRegen Prime
- MaioRegen Prime Oval
- MaioRegen Slim
- MaioRegen Slim Oval
- RegenOss
- RegenOss ABR
- RegenOss Ortho
- RegenOss Spine
- SINTlife Ortho
Showing 12 of 110 declared devices.
Catalogue references include 01600275, 01600285, 01600291, 01600300, 01600303, 01600306.
European nomenclature codes declared: P900402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FIN-CERAMICA FAENZA SPA (IT) · FDA 3006130229 |
| Devices in EUDAMED | 110 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 110 |
|---|---|
| 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: United States only. Fin-ceramica faenza spa is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CVD0005230226 | issued | 2028-03-12 |
CVD000423 | issued | 2028-03-12 |
CSQ0008230326 | issued | 2028-03-12 |
C787129 | issued | 2031-03-10 |