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Biosynex Combo Covid-Flu-Rsv Bss

by BIOSYNEX Swiss SA Switzerland EUDAMED

Ref SW40011Model BIOSYNEX COMBO COVID-FLU-RSV BSS EMDN W0105099099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03532678600222 Basic UDI-DIDate7 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
BIOSYNEX COMBO COVID-FLU-RSV BSS, SW40011
Primary DI / UDI-DI
03532678600222
Basic UDI-DI
B-03532678600222
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000024717
Authorised representative
BIOSYNEX FR-AR-000014076

Other devices from BIOSYNEX Swiss SA

See all devices from BIOSYNEX Swiss SA →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c2ac743a-c580-4013-a696-907da20620d1 61 fields · synced 24 Oct 2026