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Sodium Hyaluronate Ophthalmic Solutions

by Biotech Europe Meditech Inc Limited EUDAMED

Withdrawn Not intended for the EU market

Ref Optiflex HA 14mg/ml, 1ml PFS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153319OVDMC Basic UDI-DIDate27 Jul 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sodium Hyaluronate Ophthalmic Solutions
Model / Reference
Optiflex HA 14mg/ml, 1ml PFS
Primary DI / UDI-DI
05391533198933
Basic UDI-DI
539153319OVDMC
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
IE-MF-000004695

Other devices from Biotech Europe Meditech Inc Ltd

Properties

  • 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