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Fully Automated Chemiluminescence Immunoassay Analyzer

by Shenzhen Dake Medical Technology Co., Ltd China EUDAMED

Ref N/AModel Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc

EMDN W0201020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523FACIAN3 Basic UDI-DIDate22 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Fully Automated Chemiluminescence Immunoassay Analyzer
Model / Reference
Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39, Bright i60, Bright i66, Bright i68, Bright i69 models), Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models), etc, N/A
Primary DI / UDI-DI
06978465230284
Basic UDI-DI
697846523FACIAN3
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Dake Medical 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 db7a5acf-ee93-4118-8449-2837c2e5afc1 61 fields · synced 23 Oct 2026