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Fully Automatic ELISA Analyzer

by Changsha Imadek Intelligent Technology Co., Ltd. China EUDAMED

Ref ME-4000PlusModel ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800

EMDN W02010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697431271MEYU Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800, ME-4000Plus
Primary DI / UDI-DI
06974312710053
Basic UDI-DI
697431271MEYU
Direct Marketing DI
06974312710053
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042852
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Changsha Imadek Intelligent Technology Co., Ltd.

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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 0c41593c-013e-4f11-9d7c-a7a9273c092b 61 fields · synced 22 Oct 2026