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Carbohydrate Antigen 19-9 Quantitative Diagnostic Kit (CLIA)

by Darui Biotechnology Co., Ltd. 2 variants

Ref DR-CLIA-CM-A009Model 100 tests/kit

Active European Union

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974671100465 Basic UDI-DI 06974671100465UDI-DIDate30 Jan 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Carbohydrate Antigen 19-9 Quantitative Diagnostic Kit (CLIA)
Model / Reference
100 tests/kit, DR-CLIA-CM-A009
Primary DI / UDI-DI
06974671100465
Basic UDI-DI
B-06974671100465
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000030310
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Darui Biotechnology Co., Ltd.

See all devices from Darui Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No