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Optitrol SeroNeg

by DiaMex GmbH Germany EUDAMED

Ref SR11002

EMDN W0105080807

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426046567SRSeroNegZ5 Basic UDI-DIDate22 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SR11002
Primary DI / UDI-DI
4260465670392
Basic UDI-DI
426046567SRSeroNegZ5
Direct Marketing DI
4260465670392
EMDN Code
W0105080807 Multiconstituent controls - inf.imm.
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Other devices from DiaMex GmbH

See all devices from DiaMex GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • 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 (1)

  • EUDAMED fb66ee62-02ad-4c10-b3f3-4c99e6af5363 61 fields · synced 22 Oct 2026