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PearLens 4H

by Optaline for Medical Devices Egypt EUDAMED

Ref AH611ABP2350Model AH611ABP

EMDN P030102090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06223006823662 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hydrophobic Acrylic Foldable IOL
Model / Reference
AH611ABP, AH611ABP2350
Primary DI / UDI-DI
06223006823662
Basic UDI-DI
B-06223006823662
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000016347
Authorised representative
Qualitech International B.V. NL-AR-000002908

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06223006823662|B-06223006823662 61 fields · synced 24 Oct 2026