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Fluconazole

by Oxoid Ltd

Ref CT1806B

Fluconazole (CT1806B) is a device classified as IVD General made by Oxoid Ltd, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI B-05032384142644), active as of 24 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05032384142644 Basic UDI-DI 05032384142644UDI-DIDate24 Aug 2026RegisteredStatusActive

Official records

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  • Withdrawn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

Model / reference
CT1806B
Primary DI / UDI-DI
05032384142644
Basic UDI-DI
B-05032384142644
EMDN code
W010403060101 Susceptibility testing systems for yeasts and fungi - manual
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000016914
Authorised representative
Thermo Fisher Diagnostics B.V. NL-AR-000013157

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Properties

  • Reagent
  • Professional testing
Other properties (10, all answered No)