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LyoSens™

by Vitrosens Biotechnology Inc. 125 variants

Ref PCR67Model LYO67WS96

LyoSens™ (PCR67) is a device classified as IVD General (EU), Class C (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-08685115808783), active as of 22 Oct 2026.

Active European Union

CE IVDR CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685115808783 Basic UDI-DI 08685115808783UDI-DIDate14 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685115808783 Basic UDI-DI 08685115808783UDI-DIDate14 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device name
Lyme Disease qPCR Kit
Model / reference
LYO67WS96, PCR67
Primary DI / UDI-DI
08685115808783
Basic UDI-DI
B-08685115808783, 868511580PCR67JS
EMDN code
W0105010605 Lyme detection by na reagents
Device class
Class IVD General
Class C
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Similar devices in this category

Other devices filed under LYME BORRELIOSIS.

Other devices from Vitrosens Biotechnology Inc.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)