Alfa Intes Industria Terapeutica Splendore S.r.l.
IT-MF-000025980 · Italy · Casoria
Alfa Intes Industria Terapeutica Splendore S.r.l. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class I | 2 |
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- Idroflog
- Oftaial
- Oftaial Plus
Catalogue references include 5010097, 5010110, 592, 599, 610, 611.
European nomenclature codes declared: Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. Alfa Intes Industria Terapeutica Splendore S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CVD0029240126 | issued | 2029-06-13 |
CVD0028240125 | supplemented | 2029-06-13 |
CSQ0023240326 | supplemented | 2029-06-13 |
0425-MDR-030191-00 | issued | 2031-05-12 |