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SoToxa Oral Fluid Mobile Test System

by Abbott Toxicology Ltd 12 variants

Ref TOX400P

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50563935TOX0001QY Basic UDI-DI 05056393500004UDI-DIDate20 Aug 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  • Withdrawn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

Device Name
SoToxa Oral Fluid Mobile Test System
Model / Reference
TOX400P
Primary DI / UDI-DI
05056393500004
Basic UDI-DI
50563935TOX0001QY
EMDN Code
W0201020299 Limited panel immunochemistry analysers - other
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

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

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Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

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