DEPOFARMA S.P.A.
IT-MF-000027122 · Italy · Preganziol
DEPOFARMA S.P.A. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 6 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: 1 tube of 30 ml + anal applicator; 10 single-dose vials of 2.2 ml each, 1 tube of 35 ml + 5 single-use vaginal applicators; Free sample – not , 2 silver trilaminate caps; Free sample - not for sale (1 silver trilam, 2 tubes of 30 ml + 2 anal applicators; Free sample - not for sale (1 t.
Devices declared under this manufacturer
- Emorsan Gel (30 ml tube + 1 anal applicator)
- Emorsan Gel (Free sample not for sale: 30 ml tube filled to 10 ml + 1
- Emorsan Rag (2 x 30 ml tubes + 2 anal applicators)
- Emorsan Rag (Free sample - not for sale: 30 ml tube filled to 10 ml +
- Immunovag (35 ml tube + 5 single-use vaginal applicators)
- Immunovag (Free sample - not for sale: 35 ml tube filled to 10 ml + 1
- Silver Cap
- Silver Cap (Free sample not for sale: 1 silver trilaminate cup)
Catalogue references include 1DEP00950, 1DEP00955, 1DEP01400, 1DEP01455, 1DEP02100, 1DEP02150.
European nomenclature codes declared: M04040502, U1003, U0803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. DEPOFARMA S.P.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 000128-A | issued | 2030-11-16 |