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by Autobio Diagnostics Co., Ltd. China EUDAMED

Ref CMB0105Model AutoLumo analyzer

EMDN W0102039001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697015090000006GU Basic UDI-DIDate14 Aug 2024RegisteredStatusActive

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
AutoLumo analyzer, CMB0105
Primary DI / UDI-DI
06942359548915
Basic UDI-DI
697015090000006GU
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class C
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
  • New Device
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 52c3bc8e-fa12-4a2e-9698-5f0b1f6393a6 61 fields · synced 22 Oct 2026