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Streptococcus pneumoniae Test Cassette (Urine/Cerebral Spinal Fluid)

by Citest Diagnostics Inc EUDAMED

Active European Union

Ref FISPACI

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FISPACI6U Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD 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
Streptococcus pneumoniae Test Cassette (Urine/Cerebral Spinal Fluid)
Model / Reference
FISPACI
Primary DI / UDI-DI
D-FISPACI6U
Basic UDI-DI
B-FISPACI6U
EMDN Code
W0105090109 Strep. pneumoniae - rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

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

Other devices from Citest Diagnostics Inc

See all devices from Citest Diagnostics Inc →

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