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LyoSens BKV qPCR Kit

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref LYO97Model LYO97WS96 EMDN W0105040522

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08685115806093 Basic UDI-DIDate22 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BKV qPCR Kit
Model / Reference
LYO97WS96, LYO97
Primary DI / UDI-DI
08685115806093
Basic UDI-DI
B-08685115806093
EMDN Code
W0105040522 Bk virus - na reagents
Device Class
Class IVD General
Market of Registration
Germany

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
  • Companion Diagnostics
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No

Sources (1)

  • EUDAMED b381c3af-ae73-497b-a78b-a2b7ae472978 61 fields · synced 22 Oct 2026