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EA IgG CLIA Microparticles

by Autobio Diagnostics Co., Ltd. China EUDAMED

Ref CMX0305Model EA IgG CLIA MIcroparticles

EMDN W010504040108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975577175984 Basic UDI-DIDate20 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
EA IgG CLIA MIcroparticles, CMX0305
Primary DI / UDI-DI
06975577175984
Basic UDI-DI
B-06975577175984
EMDN Code
W010504040108 Ebv ea igg
Device Class
Class IVD General
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06975577175984|B-06975577175984 61 fields · synced 24 Oct 2026