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: Acido ialuronico sale sodico 2% per iniezione intra-articolare, gel vaginale da 6 applicatori monodose da 5 ml, 10 ovuli da 2 grammi, 10 vaginal ovules of 2.0 grams, Variant A - 12 stickpack of 15 mL.
Among these devices, 49 are declared sterile, 21 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 296 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
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020-00-04-MDR | withdrawn | 2028-06-21 |
010-00-06-MDR | withdrawn | 2028-01-09 |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 |