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Optitrol Yellow

by DiaMex GmbH Germany EUDAMED

Ref SR11021, SR11029 EMDN W0105080807

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number426046567SRYellow8D Basic UDI-DIDate10 Nov 2023RegisteredStatusWithdrawn
European UnionCE/IVDR Number426046567SRYellow8D Basic UDI-DIDate10 Nov 2023RegisteredStatusWithdrawn

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  • Withdrawn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European Union — CE/IVDD, CE/IVDR Withdrawn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 22 Oct 2026

Model / Reference
SR11021, SR11029
Primary DI / UDI-DI
4260465670194, 04260465670217, 4260465670217, 04260465670194
Basic UDI-DI
426046567SRYellow8D, B-04260465670217, B-04260465670194
Direct Marketing DI
4260465670194
4260465670217
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 (4)

  • EUDAMED 17e68b8a-dbc9-4ff4-a07d-8668726f3fdd 61 fields · synced 22 Oct 2026
  • EUDAMED 04260465670217|B-04260465670217 61 fields · synced 17 May 2026
  • EUDAMED 4260465670217|426046567SRYELLOW8D 61 fields · synced 18 May 2026
  • EUDAMED 04260465670194|B-04260465670194 61 fields · synced 18 May 2026