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Sensititre Swin Software System

by Trek Diagnostic Systems Ltd

Ref SW534

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5032384SWINSoftwareZA Basic UDI-DI 05032384546114UDI-DIDate6 Aug 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  • Withdrawn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

Model / Reference
SW534
Primary DI / UDI-DI
05032384546114
Basic UDI-DI
5032384SWINSoftwareZA
EMDN Code
W0203010192 Antibiotic susceptibility analysers - IVD medical device software
Device Class
Class B
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000016922
Authorised representative
Thermo Fisher Diagnostics B.V. NL-AR-000013157

Other devices from Trek Diagnostic Systems Ltd

See all devices from Trek Diagnostic Systems Ltd →

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