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AquaLens 4H

by Optaline for Medical Devices Egypt EUDAMED

Ref AH611ALP2000Model AH611ALP

EMDN P030102090202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06223006822986 Basic UDI-DIDate24 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
Hydrophilic Acrylic Foldable IOL
Model / Reference
AH611ALP, AH611ALP2000
Primary DI / UDI-DI
06223006822986
Basic UDI-DI
B-06223006822986
EMDN Code
P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC 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

Other devices from Optaline for Medical Devices

See all devices from Optaline for Medical Devices →

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 06223006822986|B-06223006822986 61 fields · synced 24 Oct 2026