OPTILAB S.R.L.
IT-MF-000026824 · Italy · TORINO
OPTILAB S.R.L. is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 50 |
|---|
Most frequent device types declared: BIO-GEL, BIO-SIL.
Among these devices, 24 are declared sterile.
Devices declared under this manufacturer
- BIO-GEL 45% TORICA
- BIO-GEL 54% TORICA
- BIO-GEL 55% VARI VUE
- BIO-GEL 55% torica
- BIO-GEL 58% SFERICA
- BIO-GEL 58% VARI VUE
- BIO-GEL 74% PEDIATRICA
- BIO-SIL BT HDS
- BIO-SIL K ES
- BIO-SIL K HDS
- BIO-SIL K XO
- BIO-SIL VARI VUE OPT CLASSIC
Showing 12 of 50 declared devices.
Catalogue references include 003, 005, 006, 008, 021, 023.
European nomenclature codes declared: Q02100402, Q0210040102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 50 |
| 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 | 50 |
|---|---|
| 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. OPTILAB S.R.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
066/MDR | issued | 2027-12-20 |