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Optitrol Blue

by DiaMex GmbH Germany EUDAMED

Ref SR11011Model Optitrol Blue EMDN W0105080807

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number426046567SRBlueSF Basic UDI-DIDate22 Apr 2025RegisteredStatusWithdrawn
European UnionCE/IVDR Number426046567SRBlueSF Basic UDI-DIDate22 Apr 2025RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
SR11011, Optitrol Blue
Primary DI / UDI-DI
4260465670163, 04260465670163
Basic UDI-DI
426046567SRBlueSF, B-04260465670163
Direct Marketing DI
4260465670163
EMDN Code
W0105080807, W0105080899
Device Class
Class B
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues YesEUDAMEDNoEUDAMED
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED af7c903a-e4e0-4bff-a8f4-8fb0ce14b9f5 61 fields · synced 23 Oct 2026
  • EUDAMED 04260465670163|B-04260465670163 61 fields · synced 19 May 2026