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Kiestra Synapsys

by BD Kiestra B.V. 2 variants

Ref 444902

Active European Union

CE IVDR

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/IVDR Number038290QENGHYRYDS Basic UDI-DI 00382904449025UDI-DIDate14 Oct 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
BD Kiestra™ Urine Culture Application (UCA) powered by BD Synapsys™Informatics Solution
Model / Reference
444902
Primary DI / UDI-DI
00382904449025
Basic UDI-DI
038290QENGHYRYDS
EMDN Code
W02039092 Various microbiology instruments - IVD medical device software
Device Class
Class B
Special Device Type
Software
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
NL-MF-000018863

Other devices from BD Kiestra B.V.

See all devices from BD Kiestra B.V. →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No