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Intacs® Corneal Implants

by Ajl Ophthalmic, S.a EUDAMED

Active European Union

Ref ICIA-210/300-150Model ISKS, ISK, ISKA, ICIS, ICI, ICIA

Regulatory status

as of 26 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  • Withdrawn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

Model / Reference
ISKS, ISK, ISKA, ICIS, ICI, ICIA, ICIA-210/300-150
Primary DI / UDI-DI
08435194335867
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000267

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