BONE SYSTEM SRL
IT-MF-000040985 · Italy · Garbagnate Milanese (MI)
BONE SYSTEM SRL is registered in the European database on medical devices as a manufacturer, with 506 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 399 |
|---|---|
| Class IIa | 107 |
Most frequent device types declared: Dental implant (monophasic), Two-stage dental implant.
Among these devices, 138 are declared sterile, 399 implantable, 107 reusable, 107 active.
Devices declared under this manufacturer
- 2P
- PARADIGMA MINI
Showing 12 of 506 declared devices.
Catalogue references include 11K30201, 12K30801, 13K00201, 20101801, 20204510, 83028K.
European nomenclature codes declared: P010299, P01020101, L1508, Q010280, L159099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 506 |
| 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 | 506 |
|---|---|
| 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. BONE SYSTEM SRL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030161-00 | issued | 2030-12-01 |