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LyoSens SARS-CoV-2/FLU/RSV Genotyping qPCR Kit

by Vitrosens Biotechnology Inc.

Ref LYO02Model LYO02WS96

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08684998276382 Basic UDI-DI 08684998276382UDI-DIDate22 Feb 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08684998276382 Basic UDI-DI 08684998276382UDI-DIDate22 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Trade Name
LyoSens SARS-CoV-2/FLU/RSV Genotyping qPCR Kit
LyoSens™
Device Name
SARS-CoV-2/FLU/RSV Genotyping qPCR Kit
Model / Reference
LYO02WS96, LYO02
Primary DI / UDI-DI
08684998276382
Basic UDI-DI
B-08684998276382, 868499827PCR02XD
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
Device Class
Class IVD General
Class B
EU market of registration
Germany
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

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See all devices from Vitrosens Biotechnology Inc. →

Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics YesEUDAMEDNoEUDAMED
  • Surgical Instrument YesEUDAMEDNoEUDAMED

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • New Device: No