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Xpert®

by Cepheid 17 variants

Ref GXBLAD-CD-CE-10

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07332940002268 Basic UDI-DI 07332940002268UDI-DIDate28 May 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  • Withdrawn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
Xpert® Bladder Cancer Detection
Model / Reference
GXBLAD-CD-CE-10
Primary DI / UDI-DI
07332940002268
Basic UDI-DI
B-07332940002268
EMDN Code
W01060215 Bladder cancer detection / monitoring
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000010979
Authorised representative
Cepheid AB SE-AR-000048904

Other devices from Cepheid

See all devices from Cepheid →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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