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Healon Duet Pro Ii

by AMO Uppsala AB Sweden EUDAMED

Ref 10301016 EMDN Q02030301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5050474a000679Y Basic UDI-DIDate9 Apr 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  • Withdrawn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)
  • 2253736CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    20 Feb 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
10301016
Primary DI / UDI-DI
05050474755123
Basic UDI-DI
5050474a000679Y
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
SE-MF-000017467

Other devices from AMO Uppsala AB

See all devices from AMO Uppsala AB →

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 1c885cf3-8975-4977-9f84-6d74e722caf0 61 fields · synced 22 Oct 2026