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Chemiluminescence Digital Imaging Analyzer

by Sino-Swed TongKang Bio-Tech (Shenzhen) Limited. EUDAMED

Active European Union

Ref /Model CIS-2E: Chemiluminescent Imaging System Type 2E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970698569506 Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
CIS-2E: Chemiluminescent Imaging System Type 2E, /
Primary DI / UDI-DI
06970698569506
Basic UDI-DI
B-06970698569506
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000033668
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.

Properties

  • Professional Testing

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
  • Surgical Instrument: No