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Carbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA)

by Hangzhou Realy Tech Co., Ltd.

Ref C2KA003

Active European Union

CE IVDR CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06971792054417 Basic UDI-DI 06971792054417UDI-DIDate27 Oct 2023RegisteredStatusActive
European UnionCE/IVDD NumberB-06971792054417 Basic UDI-DI 06971792054417UDI-DIDate27 Oct 2023RegisteredStatusActive

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  • Withdrawn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, CE/IVDD Active

Specification

EUDAMED

Device Name
Carbohydrate Antigen 19-9 (CA19-9) Assay Reagent Kit (CMIA)
Model / Reference
C2KA003
Primary DI / UDI-DI
06971792054417
Basic UDI-DI
B-06971792054417, 697179205C2KA003BW
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class IVD General
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000004716
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Hangzhou Realy Tech Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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