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One Step Ketamine (KET) Saliva Test

by Abiores Technology (Beijing) Co., Ltd. EUDAMED

Active European Union

Ref AD03-S20Model Cassette

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06958982140709 Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Cassette, AD03-S20
Primary DI / UDI-DI
06958982140709
Basic UDI-DI
B-06958982140709
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000022952
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Abiores Technology (Beijing) Co., Ltd.

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Properties

Show properties
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No