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Fully Automated Chemiluminescence Immunoassay Analyzer

by Shenzhen Dake Medical Technology Co., Ltd 24 variants

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

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523FACIAN3 Basic UDI-DI 06978465230239UDI-DIDate22 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

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
06978465230239
Basic UDI-DI
697846523FACIAN3
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
EU market of registration
Austria

Manufacturer details

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

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Properties

  • 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