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SoToxa

by Abbott Toxicology Ltd 2 variants

Ref TOX403

Active European Union

CE IVDR

Valid until

21 Nov 2027

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 Number50563935TOX0002R2 Basic UDI-DI 05056393501261UDI-DIDate18 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 748842 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Jul 2026
    Expires
    21 Nov 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
SoToxa Oral Fluid Test Kit
Model / Reference
TOX403
Primary DI / UDI-DI
05056393501261
Basic UDI-DI
50563935TOX0002R2
EMDN Code
W0102090199 Drugs of abuse - other
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000001885
Authorised representative
Abbott Rapid Dx International Limited IE-AR-000000091

Other devices from Abbott Toxicology Ltd

See all devices from Abbott Toxicology Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No