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LyoSens SARS-CoV-2 & Flu & RSV Detection qPCR Kit

by Vitrosens Biotechnology Inc. 2 variants

Ref LYO02, LYO02WS24

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08683548258427 Basic UDI-DI 08683548258427UDI-DIDate4 Apr 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-08683548258427 Basic UDI-DI 08683548258427UDI-DIDate4 Apr 2024RegisteredStatusActive

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  • Withdrawn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 Detection qPCR Kit
LyoSens™
Device Name
SARS-CoV-2 & Flu & RSV Detection qPCR Kit
SARS-CoV-2/FLU/RSV Genotyping qPCR Kit
Model / Reference
LYO02, LYO02WS24
Primary DI / UDI-DI
08683548258427
Basic UDI-DI
B-08683548258427, 868499827PCR02XD
EMDN Code
W0105040504, W0105040505, W0105040519, W0105070304
Device Class
Class IVD General
Class B
EU market of registration
Germany
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties

  • Reagent
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Companion Diagnostics YesEUDAMEDNoEUDAMED
  • Surgical Instrument YesEUDAMEDNoEUDAMED

Other properties (6)

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