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Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

by Shenzhen Dake Medical Technology Co., Ltd 4 variants

Ref 100 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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 linked in EUDAMED

A group certificate may exist

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 Number697846523ProteinC06RP Basic UDI-DI 06978465237320UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
25 tests，50 tests，2×50 tests，100 tests，2×100 tests, 100 tests
Primary DI / UDI-DI
06978465237320
Basic UDI-DI
697846523ProteinC06RP
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class C
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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