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BIOSYNEX Autotest de infección urinaria

by Biosynex EUDAMED

Active European Union

Ref 859278

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03532678592787 Basic UDI-DIDate20 May 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  • Withdrawn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

Device Name
Biosynex Autotest Infection Urinaire
Model / Reference
859278
Primary DI / UDI-DI
03532678592787
Basic UDI-DI
B-03532678592787
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD devices for self-testing
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties

  • Reagent
  • Self Testing

Other properties (8)

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