IBSA FARMACEUTICI ITALIA SRL
IT-MF-000008111 · Italy · lodi
IBSA FARMACEUTICI ITALIA SRL is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 10 |
|---|---|
| Class IIb | 6 |
| Class IIa | 4 |
Most frequent device types declared: 70CR02 - 70CR04, 73IS02, 72TA01.
Among these devices, 10 are declared sterile, 9 implantable, 9 active.
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 | Registered with FDA |
|---|---|
| Matched entry | IBSA Farmaceutici Italia Srl (IT) · FDA 3008280916 |
| Devices in EUDAMED | 20 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.24/5650 | issued | 2027-06-06 |
EPT 0477.MDR.24/5649 | issued | 2027-06-06 |
EPT 0477.MDR.23/5076.2 | reissued | 2027-06-06 |
EPT 0477.MDR.22/4994.2 | reissued | 2027-06-06 |
EPT 0477.MDR.22/4992.3 | reissued | 2027-06-06 |
EPT 0477.MDR.22/4844 | issued | 2027-06-06 |
EPT 0477.MDR.22/4843 | issued | 2027-06-06 |
EPT 0477.MDR.22/4842.3 | reissued | 2027-06-06 |