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Tecnis Eyhance IOL with Tecnis Simplicity Delivery System

by Johnson & Johnson Surgical Vision, Inc. United States EUDAMED

Ref DIB00I0210

EMDN P030102090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5050474a000239C Basic UDI-DIDate6 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2252965TD02 Restricted

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    16 Jul 2025
    Expires
    1 Oct 2028
    Reason
    Other
  • 2252965CE02 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    16 Jul 2025
    Expires
    1 Mar 2027
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Tecnis Eyhance Monofocal Simplicity Preloaded IOL
Model / Reference
DIB00I0210
Primary DI / UDI-DI
05050474655423
Basic UDI-DI
5050474a000239C
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

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

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See all devices from Johnson & Johnson Surgical Vision, Inc. →

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 05050474655423|5050474A000239C 61 fields · synced 24 Oct 2026