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Biosynex Ampliflash Gbs

by Biosynex France EUDAMED

Ref 3150072Model BIOSYNEX AMPLIFLASH GBS EMDN W0105011104

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00157P8N Basic UDI-DIDate5 Aug 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BIOSYNEX AMPLIFLASH GBS, 3150072
Primary DI / UDI-DI
03532678599700
Basic UDI-DI
353267F00157P8N
EMDN Code
W0105011104 Strep. b detection by na reagents
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

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Properties & raw data

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

Sources (1)

  • EUDAMED 1fe142db-5274-4dee-a437-2c28275ac3a4 61 fields · synced 24 Oct 2026