S.I.I.T. srl
IT-MF-000022188 · Italy · Trezzano sul Naviglio (Milan)
S.I.I.T. srl is registered in the European database on medical devices as a manufacturer, with 397 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 392 |
|---|---|
| Class IIb | 5 |
Most frequent device types declared: GC04B1 (10,136 g with excipients), GC04B2 (10 g), GC04M2 (6,65 g + excipients), GC05C, GC09.
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- DICOPEG junior (4 sachets)
- Diplomag IBS ummetus (20 stick packs)
- EFFECOL 3350 EPSILON HEALTH (12 sachets)
- Easygastril Magen-Gelof (20 stick packs)
- Effecol PrepEpsilon Health
- Entogol (10 sachets)
- Gastriact Antiacido (20 tablets)
- Iberolax (10 sachets)
- Lubrimil (2 stick pack - sample)
- Lubrimil 20 stick packs)
- Macrogol per colonscopia
- MeteoGaz
Showing 12 of 397 declared devices.
Catalogue references include GC04B1 (10,136 g with excipients), GC04B2 (10 g), GC04M2 (6,65 g + excipients), GC05C, GC09, GC13.
European nomenclature codes declared: G0401, Q0399, Q030199, G99, Q030103, U0803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 397 |
| 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 | 5 |
|---|---|
| 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. S.I.I.T. srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
065-00-03-MDR | supplemented | 2029-11-20 |