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LyoSens™

by Vitrosens Biotechnology Inc. 122 variants

Ref PCR164, LYO164WS96Model LYO164WS48, LYO164WS24

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685214525291 Basic UDI-DI Date4 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685214525291 Basic UDI-DI Date4 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  • Withdrawn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/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
MTB/MDR Genotyping qPCR Kit
Model / Reference
LYO164WS48, PCR164, LYO164WS24, LYO164WS96
Primary DI / UDI-DI
08685214525291, 08685214525253, 08685214525338
Basic UDI-DI
B-08685214525291, B-08685214525253, 868521452PCR164GE, B-08685214525338
EMDN Code
W0105010703 Mycobacterial detection by na reagents
Device Class
Class IVD General
Class C
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