Biofarma S.r.l.
IT-MF-000024710 · Italy · Mereto di Tomba
Biofarma S.r.l. is registered in the European database on medical devices as a manufacturer, with 70 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 65 |
|---|---|
| Class I | 4 |
| Class IIb | 1 |
Among these devices, 1 are declared sterile, 1 implantable.
Devices declared under this manufacturer
- ARCID STICKS
- Aspumex Combo
- DulcoSoft GO
- Dulcosoft Irregolarità e Gonfiore
- ESOXX ONE
- GastroBalance Reflu
- Hialsorb
- LENOID
- MAKROGOL
- Maalox RefluRAPID
- Maalox RefluRAPID Advance
- SEDAPEG4000
Showing 12 of 70 declared devices.
Catalogue references include NA.
European nomenclature codes declared: G0401, Q0399, P900402, G05, G0499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 70 |
| 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 | 1 |
|---|---|
| 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. Biofarma S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CSQ002925 | issued | 2030-06-04 |