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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR54, LYO54WS48Model LYO54WS96, LYO54WS24

EMDN W0105070501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685115805614 Basic UDI-DIDate10 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685115805614 Basic UDI-DIDate10 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
CT/NG/MG Genotyping qPCR Kit
Model / Reference
LYO54WS96, PCR54, LYO54WS24, LYO54WS48
Primary DI / UDI-DI
08685115805614, 08683548258960, 08685115805577
Basic UDI-DI
B-08685115805614, B-08683548258960, 868511580PCR54JH, B-08685115805577
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - 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 (6)

  • EUDAMED 56ad0082-635e-48a7-84dc-adca8081cb84 61 fields · synced 23 Oct 2026
  • EUDAMED 08683548258960|B-08683548258960 61 fields · synced 10 Oct 2026
  • EUDAMED 08683548258960|868511580PCR54JH 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115805577|868511580PCR54JH 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115805577|B-08685115805577 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115805614|868511580PCR54JH 61 fields · synced 24 Oct 2026