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Rapid Response Gabapentin Test Strip (Urine)

by BTNX Inc EUDAMED

Active European Union

Ref GAB-1S26-100

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10722066011512 Basic UDI-DIDate28 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Rapid Response Gabapentin Test Strip (Urine)
Model / Reference
GAB-1S26-100
Primary DI / UDI-DI
10722066011512
Basic UDI-DI
B-10722066011512
EMDN Code
W0102090199 Drugs of abuse - other
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CA-MF-000050175
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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