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Sample Release Reagent

by Autobio Diagnostics Co., Ltd. China EUDAMED

Ref CMT1402Model AutoLumo analyzer

EMDN W01029003

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697015090000360HH Basic UDI-DIDate31 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AutoLumo analyzer, CMT1402
Primary DI / UDI-DI
06975577178923
Basic UDI-DI
697015090000360HH
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
Device Class
Class A
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06975577178923|697015090000360HH 61 fields · synced 24 Oct 2026