FB VISION S.p.A.
IT-MF-000020083 · Italy · San Benedetto del Tronto
FB VISION S.p.A. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 24 |
|---|
Most frequent device types declared: LACRICOMPLEX, LUMIXA, OZODROP.
Among these devices, 24 are declared sterile, 12 with a measuring function.
Devices declared under this manufacturer
- AQUORAL LIPO 3ML MUESTRA
- LUMIXA 10 ml
- LUMIXA 3 ml / CAMP
- LUMIXA Flacone da 10 ml
- LUMIXA adv 10 ml
- Lacricomplex 10ml
- Lacricomplex 10ml – ENG
- Lacricomplex 3ml
- Lacricomplex 3ml – ENG
- OPTICOL CROSSLIP AMOSTRA 3 ml
- Ozodrop 3 mL
- Ozodrop 8 mL
Showing 12 of 24 declared devices.
Catalogue references include 00331710GB, 00561720IT, 00671700ES, 00691700PT, 10051710IT, 10321710GB.
European nomenclature codes declared: Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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 | 24 |
|---|---|
| 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. FB VISION S.p.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT328004 | issued | 2028-12-19 |
0425-MDR-030111-00 | issued | 2029-12-18 |