GRUPPO FARMAIMPRESA SRL
IT-MF-000012625 · Italy · BRESCIA
GRUPPO FARMAIMPRESA SRL is registered in the European database on medical devices as a manufacturer, with 296 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 211 |
|---|---|
| Class IIb | 64 |
| Class I | 21 |
Most frequent device types declared: 10 ovuli da 2 grammi, 15 FIALE DA 5ml, Sample - Variant A - 3 stickpack of 15 mL, VARIANT A: 15 VIALS OF 5ML, VARIANT G- 12 STICKPACK OF 15ml.
Among these devices, 49 are declared sterile, 21 implantable.
Devices declared under this manufacturer
- ALGIBABY SOD
- Caregyn ovules
- Flatta drops 20 mL
- Gynacid ovules
- HYPERNEB AEROSOL
- NEBIOS ISO
- REFALTEX
- REFLU MAX
- REFLUCALM PLUS
- REFLUCALM PLUS L
- REFLUSSAVE
- RILEFAST SOD
Showing 12 of 296 declared devices.
Catalogue references include FT.CE.107, FT.CE.107.FC.1.12, FT.CE.107.FD.1.210, FT.CE.107.FG.15.12, FT.CE.107.FH.1.300, FT.CE.107.FH.3.300.
European nomenclature codes declared: G0401, U0803, G99, Q030199, A02010799, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 296 |
| 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 | 84 |
|---|---|
| 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. GRUPPO FARMAIMPRESA SRL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
021-00-06-MDR | supplemented | 2028-06-21 |
020-00-04-MDR | withdrawn | 2028-06-21 |
010-00-06-MDR | withdrawn | 2028-01-09 |
009-00-20-MDR | supplemented | 2028-01-09 |