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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref LYO169WS48, PCR169

EMDN W0105041003

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number868521452PCR169GQ Basic UDI-DIDate28 Jul 2026RegisteredStatusActive
European UnionCE/IVDR Number868521452PCR169GQ Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HPV ID-16 Genotyping qPCR Kit
Model / Reference
LYO169WS48, PCR169
Primary DI / UDI-DI
08685214527172
Basic UDI-DI
868521452PCR169GQ, B-08685214527172
EMDN Code
W0105041003 Partial genotyping high-risk hpv - na reagents
Device Class
Class C
Class IVD General
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 08685214527172|868521452PCR169GQ 61 fields · synced 24 Oct 2026
  • EUDAMED 08685214527172|B-08685214527172 61 fields · synced 24 Oct 2026