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LyoSens™

by Vitrosens Biotechnology Inc. 125 variants

Part of a family of 6 devices: see the family page

Ref PCR43Model LYO43WS24, LYO43WS48

LyoSens™ (PCR43) is a device classified as IVD General (EU), Class C (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI B-08683548258908), 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/IVDR NumberB-08683548258908 Basic UDI-DI Date6 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08683548258908 Basic UDI-DI Date6 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  • Withdrawn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
HEV qPCR Kit
Model / reference
LYO43WS24, PCR43, LYO43WS48
Primary DI / UDI-DI
08683548258908, 08685115805416
Basic UDI-DI
B-08683548258908, B-08685115805416, 868511580PCR43JC
EMDN code
W0105020507 Hepatitis e virus - 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 HEPATITIS E VIRUS.

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties

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