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Accu-Tell® GHB Cassette (Urine)

by AccuBioTech Co., Ltd. China EUDAMED

Ref ABT-DOA-B435Model Cassette

EMDN W0102160599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970581432405 Basic UDI-DIDate14 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Cassette, ABT-DOA-B435
Primary DI / UDI-DI
06970581432405
Basic UDI-DI
B-06970581432405
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025172
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from AccuBioTech Co., Ltd.

See all devices from AccuBioTech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 296930c1-ae56-4134-be5c-9587cddeee6c 61 fields · synced 24 Oct 2026