Skip to content

Biosynex Ampliflash Malaria

by Biosynex France EUDAMED

Ref 3150053LModel BIOSYNEX AMPLIFLASH MALARIA

EMDN W0105050309

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00191P8Q Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BIOSYNEX AMPLIFLASH MALARIA, 3150053L
Primary DI / UDI-DI
03532679917558
Basic UDI-DI
353267F00191P8Q
EMDN Code
W0105050309 Plasmodium (malaria) - na reagents
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED cebeb45b-c6fe-4b27-a4f2-ac2ba5c3d529 61 fields · synced 22 Oct 2026