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Fasciola hepatica IgG ELISA

by Bordier Affinity Products SA Switzerland EUDAMEDGUDID

Ref 9650 Product code KHWEMDN W0105050203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640158219652 UDI-DIDate30 Sep 2022ListedStatusIn distribution
European UnionCE/IVDD EUDAMED NumberB-07640158219652 Basic UDI-DIDate22 Sep 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Fasciola hepatica total antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
9650
Primary DI / UDI-DI
07640158219652
Basic UDI-DI
B-07640158219652, 76401582196503C
Direct Marketing DI
07640158219652
FDA Product Code
KHW
EMDN Code
W0105050203 Distomatosis
GMDN Term
Fasciola hepatica total antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General EUDAMED
Class B EUDAMED
Class II GUDID
Regulation Number
866.3220
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
Class B
GUDID
Class II

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (16)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 1b2fe13e-5311-433c-8e5b-c1313f35cb3b 61 fields · synced 24 Oct 2026
  • EUDAMED 07640158219652|76401582196503C 61 fields · synced 19 May 2026
  • FDA UDI 8e182404-e296-45f1-8202-d58dc442ecbc 36 fields · synced 30 May 2026