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LyoSens™

by Vitrosens Biotechnology Inc. 100 variants

Ref LYO162WS24, PCR162Model LYO162WS96, LYO162WS48

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/IVDD Number868521452PCR162GA Basic UDI-DI Date3 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number868521452PCR162GA Basic UDI-DI Date3 Aug 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  • Withdrawn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/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
Eye Infection Genotyping qPCR Kit
Model / Reference
LYO162WS24, LYO162WS96, PCR162, LYO162WS48
Primary DI / UDI-DI
08685214525017, 08685214525093, 08685214525055
Basic UDI-DI
868521452PCR162GA, B-08685214525093, B-08685214525055, B-08685214525017
EMDN Code
W0105070502 Other multiple infectious - multiplex na reagents
Device Class
Class C
Class IVD General
EU 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

  • 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