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 IIb | 6 |
|---|---|
| Class I | 10 |
| Class IIa | 4 |
Most frequent device types declared: 70CR02 - 70CR04, 72TA01, 73IS02.
Among these devices, 10 are declared sterile, 9 implantable, 9 active.
Devices declared under this manufacturer
- ALIAMARE
- IALUSET
- IALUSET HL
- KAROS GOLA PASTIGLIE
- Perovial
- SINOGEL
Showing 12 of 20 declared devices.
Catalogue references include 8033638950814, 8033638958100, 8053689860139, 8053689860153, 8053689860191, 8053689863161.
European nomenclature codes declared: P900402, M040499, Q0399.
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 |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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: United States only. IBSA FARMACEUTICI ITALIA SRL is registered in the United States but was not found in the Canadian register.
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 |