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Intacs® Corneal Implants

by Ajl Ophthalmic, S.a Spain EUDAMED

Ref ISKS-400-90Model ISKS, ISK, ISKA, ICIS, ICI, ICIA EMDN Q0299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84351943032SC Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023 DR 0008 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0318
    Issued
    21 Nov 2023
    Expires
    20 Nov 2028

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ISKS, ISK, ISKA, ICIS, ICI, ICIA, ISKS-400-90
Primary DI / UDI-DI
08435194331906
Basic UDI-DI
84351943032SC
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000267

Other devices from Ajl Ophthalmic, S.a

See all devices from Ajl Ophthalmic, S.a →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08435194331906|84351943032SC 61 fields · synced 24 Oct 2026