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Fully Automated Chemiluminescence Immunoassay Analyzer

by Shenzhen Dake Medical Technology Co., Ltd EUDAMED

Active European Union

Model 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

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

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
Primary DI / UDI-DI
06978465230352
Market of Registration
Austria

Manufacturer details

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

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