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VITEK® REVEAL™ SOFTWARE v1.2.5

by bioMérieux, Inc.

Ref 425003

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number357302BUDI002237TR Basic UDI-DI 03573026640583UDI-DIDate23 Sep 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
425003
Primary DI / UDI-DI
03573026640583
Basic UDI-DI
357302BUDI002237TR
EMDN Code
W0203010182 Antibiotic susceptibility analysers - software accessories
Device Class
Class A
Special Device Type
Software
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000011802
Authorised representative
bioMérieux SA FR-AR-000004435

Other devices from Biomérieux

See all devices from Biomérieux →

Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (8)

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