Skip to content

Rapid Response Fentanyl Test Strip (Urine)

by BTNX Inc 2 variants

Ref FYL-1S27-100

Active European Union

CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10722066017842 Basic UDI-DI 10722066017842UDI-DIDate30 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Rapid Response Fentanyl Test Strip (Urine)
Model / Reference
FYL-1S27-100
Primary DI / UDI-DI
10722066017842
Basic UDI-DI
B-10722066017842
EMDN Code
W0102090122 Fentanyl
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

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

Other devices from BTNX Inc.

See all devices from BTNX Inc. →

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