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SERATEC Cotinine Test

by SERATEC Gesellschaft für Biotechnologie mbH Germany EUDAMED

Ref DSC-COT

EMDN W0102090108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DEMF000031456DSCCOTSB Basic UDI-DIDate26 May 2025RegisteredStatusActive

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 22 Oct 2026

Model / Reference
DSC-COT
Primary DI / UDI-DI
D-DEMF000031456DSCCOTSB
Basic UDI-DI
B-DEMF000031456DSCCOTSB
EMDN Code
W0102090108 Cotinine
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
DE-MF-000031456

Other devices from SERATEC Gesellschaft für Biotechnologie mbH

Properties & raw data

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

Sources (1)

  • EUDAMED a067d37f-2bda-4ce1-aca0-ea2e3d6e9045 61 fields · synced 22 Oct 2026