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Fluorescence Immunoassay Analyzer

by Citest Diagnostics Inc EUDAMED

Active European Union

Ref CTA-FAM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84100700014E5V Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Fluorescence Immunoassay Analyzer
Model / Reference
CTA-FAM
Primary DI / UDI-DI
00841007016331
Basic UDI-DI
84100700014E5V
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
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

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No