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LyoSens™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref LYO152WS24, PCR152, LYO152WS96, LYO152WS48

EMDN W0105070503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number868521452PCR152G7 Basic UDI-DIDate21 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number868521452PCR152G7 Basic UDI-DIDate21 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Respiratory v5.0 Genotyping qPCR Kit
Model / Reference
LYO152WS24, PCR152, LYO152WS96, LYO152WS48
Primary DI / UDI-DI
08685214523594, 08685214523679, 08685214523631
Basic UDI-DI
868521452PCR152G7, B-08685214523594, B-08685214523631, B-08685214523679
EMDN Code
W0105070503 Respiratory tract infections - multiplex 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 (6)

  • EUDAMED d8d0c800-6863-4fce-b5e9-2952b76ddd28 61 fields · synced 22 Oct 2026
  • EUDAMED 08685214523594|B-08685214523594 61 fields · synced 10 Oct 2026
  • EUDAMED 08685214523679|868521452PCR152G7 61 fields · synced 17 Oct 2026
  • EUDAMED 08685214523631|868521452PCR152G7 61 fields · synced 25 Oct 2026
  • EUDAMED 08685214523631|B-08685214523631 61 fields · synced 25 Oct 2026
  • EUDAMED 08685214523679|B-08685214523679 61 fields · synced 25 Oct 2026