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ZY-280 Automatic Clinical Chemistry Analyzer

by Shanghai Kehua Laboratory System Co., Ltd. China EUDAMED

Ref ZY-280Model ZY-400, ZY-450, ZY-460, ZY-480, Polaris c1000, Polaris c1100, Polaris c2000, Polaris c2100, ZY-680, ZY-690, ZY-1200, ZY-1250, ZY-1260, ZY-1280, G9800, ZY-260, ZY-280

EMDN W0201010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697484781001PY Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automatic Clinical Chemistry Analyzer
Model / Reference
ZY-400, ZY-450, ZY-460, ZY-480, Polaris c1000, Polaris c1100, Polaris c2000, Polaris c2100, ZY-680, ZY-690, ZY-1200, ZY-1250, ZY-1260, ZY-1280, G9800, ZY-260, ZY-280
Primary DI / UDI-DI
06974847810167
Basic UDI-DI
697484781001PY
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000017428
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Shanghai Kehua Laboratory System Co., Ltd.

See all devices from Shanghai Kehua Laboratory System 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 96bbd7de-0188-47b1-9956-3ed7f24bf65d 61 fields · synced 24 Oct 2026