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POCLia8

by Taizhou Zecen Biotech Co., Ltd. China EUDAMED

Ref Chemiluminescence Immunoassay Analyzer EMDN W0201020101

Regulatory status

as of 25 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Chemiluminescence Immunoassay Analyzer
Model / Reference
Chemiluminescence Immunoassay Analyzer
Primary DI / UDI-DI
06974201150762
Basic UDI-DI
697420115YQ001DZ
Direct Marketing DI
06974201150762
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
France

Manufacturer details

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

Other devices from Taizhou Zecen Biotech Co., Ltd.

See all devices from Taizhou Zecen Biotech 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 71b06cd5-262a-4935-91c2-9355dd238d46 61 fields · synced 22 Oct 2026