SANADEN SRLS
IT-MF-000035916 · Italy · Garbagnate Milanese
SANADEN SRLS is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: Fiberglass Endodontic Post, Reinforcement Ribbon UHMW PE.
Among these devices, 16 are declared implantable.
Devices declared under this manufacturer
- FIBER-BRIDGE
- SANAPOST
- Sanapost
Showing 12 of 16 declared devices.
Catalogue references include 08-2Wa, 10-2W, 12-2Wa, 40-2Wh, FB H2a, FB H3a.
European nomenclature codes declared: Q010105, Q010199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| 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 | 12 |
|---|---|
| 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. SANADEN SRLS was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030127-00 | issued | 2030-03-09 |