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LyoSens™

by Vitrosens Biotechnology Inc. 11 variants

Ref LYO07WS24, PCR07

LyoSens™ (LYO07WS24) is a device classified as Class B (EU), IVD General (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 868499827PCR07XP), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number868499827PCR07XP Basic UDI-DI 08684595035191UDI-DIDate1 Oct 2026RegisteredStatusActive
European UnionCE/IVDR Number868499827PCR07XP Basic UDI-DI 08684595035191UDI-DIDate1 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device name
Shigella(EIEC) qPCR Kit
Model / reference
LYO07WS24, PCR07
Primary DI / UDI-DI
08684595035191
Basic UDI-DI
868499827PCR07XP, B-08684595035191
EMDN code
W0105011614 Shigella - na reagents
Device class
Class B
Class IVD General
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Similar devices in this category

Other devices filed under OTHER BACTERIOLOGY - NA REAGENTS.

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Properties

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