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Chemiluminescence Immunoassay Analyzer

by Aikang Diagnostics Co., Ltd China EUDAMED

Ref CLIA-mate PlusModel CLIA-mate 1200, CLIA-mate Plus EMDN W0201010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697335604A001BX Basic UDI-DIDate28 May 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
CLIA-mate 1200, CLIA-mate Plus
Primary DI / UDI-DI
06973356047248
Basic UDI-DI
697335604A001BX
Direct Marketing DI
06973356047248
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028962
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Aikang Diagnostics Co., Ltd

See all devices from Aikang Diagnostics Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED cee01c18-6b84-4dc2-b6b4-f26380f5b9d3 61 fields · synced 24 Oct 2026