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LyoSens Plasmodium falciparum Detection qPCR Kit

by Vitrosens Biotechnology Inc. EUDAMED

Active European Union

Ref LYO70

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683548259882 Basic UDI-DIDate9 May 2024RegisteredStatusActive

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  • Withdrawn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
Plasmodium falciparum Detection qPCR Kit
Model / Reference
LYO70
Primary DI / UDI-DI
08683548259882
Basic UDI-DI
B-08683548259882
EMDN Code
W0104050202 Plasmodium falciparum
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000026452

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Properties

Show properties
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No