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LyoSens™

by Vitrosens Biotechnology Inc. 11 variants

Ref LYO106WS48

LyoSens™ (LYO106WS48) is a Class B device made by Vitrosens Biotechnology Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 868499827PCR106YL), active as of 7 Nov 2026.

Active European Union

CE IVDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868499827PCR106YL Basic UDI-DI 08684998275873UDI-DIDate3 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
SARS-CoV-2 qPCR Kit
Model / reference
LYO106WS48
Primary DI / UDI-DI
08684998275873
Basic UDI-DI
868499827PCR106YL
EMDN code
W0105041106 Coronavirus - na reagents
Device class
Class B
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Similar devices in this category

Other devices filed under CORONAVIRUS - NA REAGENTS.

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)