S.I.Cell S.p.A.
IT-MF-000029406 · Italy · Fiesso Umbertiano
S.I.Cell S.p.A. is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 127 |
|---|
Most frequent device types declared: ALL IN ONE DIAPER, BABY ALL IN ONE DIAPER, LIGHT INCONTINENCE, RECTANGULAR PAD, SHAPED DIAPER.
Devices declared under this manufacturer
- MEDISOFT SLIP MEDIUM NIGHT 20 PZ.
- NONA COMFORT SLIP EXTRA MEDIUM 25 PZ.
- PHARMA BREAT. LARGE NIGHT 20 PZ.
- PHARMA MEDIUM NIGHT 20 PZ.
- PHARMA SENS. EL. MEDIUM PLUS 20 PZ.
- PHARMA SENS. LARGE SUPER 15 PZ.
- PHARMA TRAVERSE 60X60 30 PZ.
- PREMIO NATURA MINI 2/6 KG. 28 PZ.
- SANIFORM NACHT SUPER 20 PZ.
- SANIFORM SOFT NACHT SUPER 20 PZ.
- SANIFORM SOFT PLUS 20 PZ.
- SANISLIP MEDIUM SUPER PLUS 20 PZ.
Showing 12 of 127 declared devices.
Catalogue references include 10000539/30659, 2022/30142, 30054, 30286, 30545, 5521/31081.
European nomenclature codes declared: T04010103, T04010102, T0499, T04010201, T04010202, T04010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | S.I.CELL S.P.A. (IT) · FDA 3008389428 |
| Devices in EUDAMED | 127 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| 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. S.I.Cell S.p.A. is registered in the United States but was not found in the Canadian register.