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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR110, LYO110WS24, LYO110WS48Model LYO110WS96

EMDN W0105040403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08684998275477 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08684998275477 Basic UDI-DIDate17 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
EBV Quantitative qPCR Kit
Model / Reference
LYO110WS96, PCR110, LYO110WS24, LYO110WS48
Primary DI / UDI-DI
08684998275477, 08684998275262, 08684998275316
Basic UDI-DI
B-08684998275477, 868499827PCR110YB, B-08684998275262, B-08684998275316
EMDN Code
W0105040403 Ebv - 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 d4136bf1-0784-42e1-b055-63f1b8656dfd 61 fields · synced 24 Oct 2026
  • EUDAMED 08684998275262|868499827PCR110YB 61 fields · synced 18 Oct 2026
  • EUDAMED 08684998275477|868499827PCR110YB 61 fields · synced 24 Oct 2026
  • EUDAMED 08684998275316|868499827PCR110YB 61 fields · synced 25 Oct 2026
  • EUDAMED 08684998275262|B-08684998275262 61 fields · synced 25 Oct 2026
  • EUDAMED 08684998275316|B-08684998275316 61 fields · synced 25 Oct 2026