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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Intacs® Corneal Implants

UDI-DI 08435194331883Basic UDI-DI 84351943032SC

Class IIb · MDR · AJL OPHTHALMIC, S.A

Identification
Model
ISKS, ISK, ISKA, ICIS, ICI, ICIA
EMDN
Q0299
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2023 DR 0008

EU technical documentation assessment · valid

Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)

Valid from 2023-11-21 · Expiry 2028-11-20

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

AJL OPHTHALMIC, S.A

SRN ES-MF-000000267

ES · Miñano , Alava

manufacturer

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Canonical device page: /device/intacs-corneal-implants-1883 · UDI page: /udi/08435194331883

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