ITALFARMACO S.A.
ES-MF-000029004 · Spain · MADRID
ITALFARMACO S.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 | 8 |
|---|
Most frequent device types declared: Vaginal moisturizing gel.
Devices declared under this manufacturer
- AINARA Vaginal moisturizing gel 30g
- AINARA Vaginal moisturizing gel 7g
- AINARA by Flavia Vaginal moisturizing gel 30g
- AINARA by Flavia Vaginal moisturizing gel 7g
- NAYARA Vaginal moisturizing gel 30g
- NAYARA Vaginal moisturizing gel 7g
- SUZANNE Vaginal moisturizing gel 30g
- SUZANNE Vaginal moisturizing gel 7g
European nomenclature codes declared: U0803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Spain |
⚠️ 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. ITALFARMACO S.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025 CR 0042 | issued | 2030-01-12 |