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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref LYO158WS96

EMDN W0105070202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868521452PCR158GK Basic UDI-DIDate3 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sepsis v2.0 Genotyping qPCR Kit
Model / Reference
LYO158WS96
Primary DI / UDI-DI
08685214524430
Basic UDI-DI
868521452PCR158GK
EMDN Code
W0105070202 Blood stream infection/sepsis (bacteria & fungi) - multiplex na reagents
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08685214524430|868521452PCR158GK 61 fields · synced 24 Oct 2026