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: ISKS, ISK, ISKA, ICIS, ICI, ICIA, VTS2000, CANA-RING.
Among these devices, 54 are declared sterile, 43 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023 DR 0008 | issued | 2028-11-20 |
2023 CR 0009 | supplemented | 2028-11-20 |