LO.LI. PHARMA S.r.l.
IT-MF-000023734 · Italy · Roma
LO.LI. PHARMA S.r.l. is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 77 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: BRONCOSITOL, EUMASTOS GEL, MONOGIN GEL, MONOGIN OVULI VAGINALI, Ovulo Vaginale / Vaginal Capsul.
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- BIGUANELLE
- BIGUANELLE GEL
- BIGUANELLE PESSARIES
- BIGUANELLE PESSARIES Vaginal pessaries
- BRONCOSITOL
- CLOTIDAL TOTAL
- HYAVAGE Vajinal Ovul
- MELAGYN OVULOS VAGINALES/ VAGINAIS
- MONOGIN GEL
- OVOSICARE VITAL
- PNEUMOXYTOL
- PREMENO Ovules Vaginaux
Showing 12 of 78 declared devices.
Catalogue references include BIGUANELLE, BIGUANELLE GEL, CLOTIDAL TOTAL, MELAGYN OVULOS VAGINALES/ VAGINAIS, MONOGIN GEL, PREMENO Ovules Vaginaux.
European nomenclature codes declared: U0899, Q0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 78 |
| 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 | 77 |
|---|---|
| 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. LO.LI. PHARMA S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT339826 | issued | 2029-04-15 |
EPT 0477.MDR.23/5060.3 | reissued | 2027-08-03 |
EPT 0477.MDR.23/5059.5 | reissued | 2027-08-03 |
EPT 0477.MDR.23/5054.1 | reissued | 2027-08-03 |
EPT 0477.MDR.22/5003.3 | reissued | 2027-08-03 |
EPT 0477.MDR.22/4914.2 | reissued | 2027-08-03 |