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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR111Model LYO111WS48

EMDN W0105011104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685115801241 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685115801241 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Strep B qPCR Kit
Model / Reference
LYO111WS48, PCR111
Primary DI / UDI-DI
08685115801241
Basic UDI-DI
B-08685115801241, 868511580PCR111G8
EMDN Code
W0105011104 Strep. b detection by 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 (2)

  • EUDAMED 08685115801241|B-08685115801241 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115801241|868511580PCR111G8 61 fields · synced 24 Oct 2026