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Tecnis Eyhance Toric II IOL

by Johnson & Johnson Surgical Vision, Inc. 590 variants

Ref ICU600I320

Expiring European Union

CE MDR

Valid until

1 Mar 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5050474a000509F Basic UDI-DI 05050474724303UDI-DIDate9 Mar 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2252965TD02 Restricted

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Oct 2028
    Reason
    Other
  • 2252965CE02 Expiring Supplemented Expires in 121 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Mar 2027
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Tecnis Eyhance Monofocal Toric II IOL
Model / Reference
ICU600I320
Primary DI / UDI-DI
05050474724303
Basic UDI-DI
5050474a000509F
EMDN Code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000038968
Authorised representative
AMO Ireland IE-AR-000013513

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Properties

  • 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