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Anti-dsDNA IgG CLIA Microparticles

by Autobio Diagnostics Co., Ltd. China EUDAMED

Ref CMQ2303Model AutoLumo analyzer EMDN W0102100105

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697015090000325HF Basic UDI-DIDate13 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
AutoLumo analyzer, CMQ2303
Primary DI / UDI-DI
06942359544061
Basic UDI-DI
697015090000325HF
EMDN Code
W0102100105 Ds DNA - antibodies
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000003348
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Autobio Diagnostics Co., Ltd.

See all devices from Autobio Diagnostics Co., Ltd. →

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 ee35e720-e5a3-4a8f-a217-7d370e298774 61 fields · synced 25 Oct 2026