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Regenera

by Eye Pharma S.p.a. Italy EUDAMED

Ref A941662633Model Regenera Therapeutic Lens

EMDN Q02100499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957143REXF Basic UDI-DIDate23 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030167-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    22 Dec 2025
    Expires
    21 Dec 2030

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Regenera Therapeutic Lens, A941662633
Primary DI / UDI-DI
08059571430046
Basic UDI-DI
805957143REXF
EMDN Code
Q02100499 Contact lenses - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026349

Other devices from Eye Pharma S.p.a.

  • Regenera

    Class IIa

  • Regenera

    Class IIa

  • Regenera

    Class IIa

  • Regenera

    Class IIa

  • Regenera

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 1849ff71-510a-4a27-bdcb-cfacf5f327db 61 fields · synced 22 Oct 2026