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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR192, LYO192WS48Model LYO192WS96

EMDN W0105040523

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685214528766 Basic UDI-DIDate20 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685214528766 Basic UDI-DIDate20 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
JCV Quantitative qPCR Kit
Model / Reference
LYO192WS96, PCR192, LYO192WS48
Primary DI / UDI-DI
08685214528766, 08685214528728
Basic UDI-DI
B-08685214528766, 868521452PCR192GK, B-08685214528728
EMDN Code
W0105040523 Jc virus - 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 (4)

  • EUDAMED 0f01bf75-ab11-4880-afe2-38ddf6773a2f 61 fields · synced 24 Oct 2026
  • EUDAMED 08685214528766|868521452PCR192GK 61 fields · synced 24 Oct 2026
  • EUDAMED 08685214528728|868521452PCR192GK 61 fields · synced 24 Oct 2026
  • EUDAMED 08685214528728|B-08685214528728 61 fields · synced 24 Oct 2026