Epitech Group SpA
IT-MF-000031026 · Italy · Milano (MI)
Epitech Group SpA is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class IIb | 5 |
Most frequent device types declared: 40 mL, 40 ml, 4x125 mL, 75 mL.
Devices declared under this manufacturer
- ALGONERV CREMA
- BALANIL GEL
- BALANIL GELIS
- EPROZEN GEL
- SAGINIL GEL
- SAGINIL GELIS
- SAGINIL SOLUZIONE VAGINALE
Catalogue references include 6028, 6030, 6402, 6404, 8015, 8027.
European nomenclature codes declared: U0803, U99, M040199, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 11 |
|---|---|
| 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. Epitech Group SpA was not found in either the U.S. or the Canadian register.