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Leishmania infantum IgG ELISA

by Bordier Affinity Products SA Switzerland EUDAMED

Ref 9500 EMDN W0105050205

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-07640158219508 Basic UDI-DIDate12 Oct 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-07640158219508 Basic UDI-DIDate12 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
9500
Primary DI / UDI-DI
07640158219508
Basic UDI-DI
B-07640158219508, 76401582195002Q
Direct Marketing DI
07640158219508
EMDN Code
W0105050205 Leishmania
Device Class
Class IVD General
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000025247
Authorised representative
Leman Diagnostics SARL FR-AR-000024185

Other devices from Bordier Affinity Products SA

See all devices from Bordier Affinity Products SA →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 81215348-7999-467d-9690-6756d39a5e33 61 fields · synced 24 Oct 2026
  • EUDAMED 07640158219508|76401582195002Q 61 fields · synced 19 May 2026