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HbA1c Test Cassette (Whole Blood)

by Citest Diagnostics Inc

Ref FI-HBA-402(CT)

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-HBA-402(CT)2G Basic UDI-DI D-FI-HBA-402(CT)2GUDI-DIDate17 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  • Withdrawn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
HbA1c Test Cassette (Whole Blood)
Model / Reference
FI-HBA-402(CT)
Primary DI / UDI-DI
D-FI-HBA-402(CT)2G
Basic UDI-DI
B-FI-HBA-402(CT)2G
EMDN Code
W0101060107 Hba1c test strips
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