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Trypan Blue Ophthalmic Solutions

by Biotech Europe Meditech Inc Limited Ireland EUDAMED

Ref Opti Blue, 1 ml PFS EMDN Q02030201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153319OSVB 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 23 Oct 2026

Device Name
Trypan Blue Ophthalmic Solutions
Model / Reference
Opti Blue, 1 ml PFS
Primary DI / UDI-DI
05391533199039
Basic UDI-DI
539153319OSVB
EMDN Code
Q02030201 Ophthalmic dyes
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IE-MF-000004695

Other devices from Biotech Europe Meditech Inc Ltd

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 e341c544-9810-49e4-8038-be5fee34a736-1 61 fields · synced 23 Oct 2026