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LIAISON® Borrelia IgM II

by DiaSorin Italia S.p.A. EUDAMED

Active European Union

Ref 310010

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number80567713100102Z Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
310010
Primary DI / UDI-DI
08056771100007
Basic UDI-DI
80567713100102Z
Direct Marketing DI
08056771100007
EMDN Code
W0105010604 Lyme antibody igm
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029422

Other devices from DiaSorin Italia S.p.A.

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No