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Optitrol Blue

by DiaMex GmbH Germany EUDAMED

Ref SR11013Model Optitrol Blue EMDN W0105080899

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260465670170 Basic UDI-DIDate9 Nov 2023RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Optitrol Blue, SR11013
Primary DI / UDI-DI
04260465670170, 4260465670170
Basic UDI-DI
B-04260465670170, 426046567SRBlueSF
Direct Marketing DI
4260465670170
EMDN Code
W0105080899, W0105080807
Device Class
Class IVD Annex II List A
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues NoEUDAMEDYesEUDAMED
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • 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 8a477f48-ec76-40b4-9330-98a4db9a5788 61 fields · synced 23 Oct 2026
  • EUDAMED 4260465670170|426046567SRBLUESF 61 fields · synced 17 May 2026