ESSILOR INTERNATIONAL
FR-MF-000007175 · France · Charenton-le-Pont
ESSILOR INTERNATIONAL is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 25 |
|---|
Among these devices, 22 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- CAMPITEST
- OST 100
- OST 150
- OST 250 C
- OST 350
- Polarized Viewer - Infant
- Polarized Viewer - Pediactric
- Polarized Viewer - Standard 3-D
- SL 500
- VISION-C 600
- VISION-R 700
- VISION-R 800
Showing 12 of 25 declared devices.
Catalogue references include C77301, C78000, OST250C, OST350, V01014, V01016.
European nomenclature codes declared: Z1212012080, Z12129001, Z1212012099, Z12120108, Z12120113, Z1212012003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ESSILOR INTERNATIONAL (FR) · FDA 3003325113 |
| Devices in EUDAMED | 25 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 44.0 % |
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. ESSILOR INTERNATIONAL is registered in the United States but was not found in the Canadian register.