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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR157, LYO157WS48Model LYO157WS24, LYO157WS96

EMDN W0105070202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685214524232 Basic UDI-DIDate31 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685214524232 Basic UDI-DIDate31 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sepsis v1.0 Genotyping qPCR Kit
Model / Reference
LYO157WS24, PCR157, LYO157WS96, LYO157WS48
Primary DI / UDI-DI
08685214524232, 08685214524317, 08685214524270
Basic UDI-DI
B-08685214524232, B-08685214524317, 868521452PCR157GH, B-08685214524270
EMDN Code
W0105070202 Blood stream infection/sepsis (bacteria & fungi) - multiplex na reagents
Device Class
Class IVD General
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 (5)

  • EUDAMED 85b2c6fe-cef6-4cf8-a807-4ad81a382dbd 61 fields · synced 23 Oct 2026
  • EUDAMED 08685214524317|B-08685214524317 61 fields · synced 17 Oct 2026
  • EUDAMED 08685214524232|868521452PCR157GH 61 fields · synced 23 Oct 2026
  • EUDAMED 08685214524270|868521452PCR157GH 61 fields · synced 24 Oct 2026
  • EUDAMED 08685214524270|B-08685214524270 61 fields · synced 25 Oct 2026