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Xpert®

by Cepheid AB 12 variants

Ref GXMRSA/SA-BC-CE-10, GXHIV-VL-XC-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 linked in EUDAMED

A group certificate may exist

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-07332940000134 Basic UDI-DI Date14 Apr 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Xpert MRSA/SA Blood Culture Assay
Xpert® HIV-1 Viral Load XC
Model / Reference
GXMRSA/SA-BC-CE-10, GXHIV-VL-XC-CE-10
Primary DI / UDI-DI
07332940000134, 07332940007409
Basic UDI-DI
B-07332940000134, B-07332940007409
EMDN Code
W0104080601, W0105030107
Device Class
Class IVD General
Class IVD Annex II List A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
SE-MF-000002020

Other devices from Cepheid AB

See all devices from Cepheid AB →

Properties

  • Animal Tissues
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing

Other properties (6)

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