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Chemiluminescence Immunoassay Analyzer

by Taizhou Zecen Biotech Co., Ltd. EUDAMED

Active European Union

Ref POCLia plus, CIA 1200M, CIA 1200, CIA 600, CIA 2800, POCLia auto

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697420115YQ001DZ Basic UDI-DIDate19 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
POCLia plus, CIA 1200M, CIA 1200, CIA 600, CIA 2800, POCLia auto
Primary DI / UDI-DI
06974201151882, 06974201152001, 06974201151998, 06974201151981, 06974201152025, 06974201151899
Basic UDI-DI
697420115YQ001DZ
Direct Marketing DI
06974201151882
06974201152001
06974201151998
06974201151981
06974201152025
06974201151899
EMDN Code
W0201020101, W0201020102, W0201020104
Device Class
Class A
Market of Registration
Germany
Italy
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000050486
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Taizhou Zecen Biotech Co., Ltd.

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Properties

  • 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