Skip to content

ST-360 Microplate Reader

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

Ref ST-360Model ST-360, ST-380, ST-960, ST-980

EMDN W0201020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697484781005Q8 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

Device Name
Microplate Reader
Model / Reference
ST-360, ST-380, ST-960, ST-980
Primary DI / UDI-DI
06974847812505
Basic UDI-DI
697484781005Q8
EMDN Code
W0201020201 Immunochemistry readers
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 3673059a-88a8-4bfd-9bf5-79306f3d4d59 61 fields · synced 22 Oct 2026