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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR113Model LYO113WS24

EMDN W0105010203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08684998277518 Basic UDI-DIDate21 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08684998277518 Basic UDI-DIDate21 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 25 Oct 2026

Device Name
Neisseria meningitidis Genotyping qPCR Kit
Model / Reference
LYO113WS24, PCR113
Primary DI / UDI-DI
08684998277518
Basic UDI-DI
B-08684998277518, 868499827PCR113YH
EMDN Code
W0105010203 Gonococcal 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 08684998277518|B-08684998277518 61 fields · synced 25 Oct 2026
  • EUDAMED 08684998277518|868499827PCR113YH 61 fields · synced 25 Oct 2026