AJL OPHTHALMIC, S.A
ES-MF-000000267 · Spain · Miñano , Alava
AJL OPHTHALMIC, S.A is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 43 |
|---|---|
| Class IIa | 12 |
Most frequent device types declared: CANA-RING, ISKS, ISK, ISKA, ICIS, ICI, ICIA, VTS2000.
Among these devices, 54 are declared sterile, 43 implantable.
Devices declared under this manufacturer
- AJL OCULAR
- AJL TUBOS DE VACIO / AJL VACUUM TUBING SET
- CANABRAVA RING
- Intacs® Corneal Implants
- VAMA
Showing 12 of 55 declared devices.
Catalogue references include ICI-210-150, ICI-230-150, ISK-210-150, ISK-350-150, ISKA-210/300-150, ISKS-210-150.
European nomenclature codes declared: Q0299, R010599, Q021106.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AJL OPHTHALMIC, S.A. (ES) · FDA 3002224346 |
| Devices in EUDAMED | 55 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 55 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 1.8 % |
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. AJL OPHTHALMIC, S.A is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023 DR 0008 | issued | 2028-11-20 |
2023 CR 0009 | supplemented | 2028-11-20 |