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CA153 Test Cassette (Whole Blood/Serum/Plasma)

by Citest Diagnostics Inc 2 variants

Ref FI-CA153-CT402

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FI-CA153-CT402WU Basic UDI-DI D-FI-CA153-CT402WUUDI-DIDate14 Sep 2026RegisteredStatusActive

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  • Withdrawn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
CA153 Test Cassette (Whole Blood/Serum/Plasma)
Model / Reference
FI-CA153-CT402
Primary DI / UDI-DI
D-FI-CA153-CT402WU
Basic UDI-DI
B-FI-CA153-CT402WU
EMDN Code
W0102030102 Cancer antigen 15-3
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CA-MF-000022516
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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