Skip to content

Optitrol Red

by DiaMex GmbH Germany EUDAMED

Ref SR11051Model Optitrol Red EMDN W0105080899

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04260465670286 Basic UDI-DIDate9 Nov 2023RegisteredStatusWithdrawn
European UnionCE/IVDD NumberB-04260465670286 Basic UDI-DIDate9 Nov 2023RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Optitrol Red, SR11051
Primary DI / UDI-DI
04260465670286, 4260465670286
Basic UDI-DI
B-04260465670286, 426046567SRRedKT
Direct Marketing DI
4260465670286
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 f27e2727-733c-44d9-b5b2-c1b298f078b4 61 fields · synced 23 Oct 2026
  • EUDAMED 4260465670286|426046567SRREDKT 61 fields · synced 19 May 2026