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Schistosoma mansoni IgG ELISA

by Bordier Affinity Products SA Switzerland EUDAMEDGUDID

Ref 9600 Product code GNHEMDN W0105050206

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED Number76401582196002V Basic UDI-DIDate21 Oct 2025RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number76401582196002V Basic UDI-DIDate21 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640158219607 UDI-DIDate9 Aug 2022ListedStatusIn distribution

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, CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
9600
Primary DI / UDI-DI
07640158219607
Basic UDI-DI
76401582196002V, B-07640158219607
Direct Marketing DI
07640158219607
FDA Product Code
GNH
EMDN Code
W0105050206 Schistosoma
GMDN Term
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class I GUDID
Regulation Number
866.3600
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
Class IVD General
GUDID
Class I

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 f97a4a01-83bc-45c0-9a10-5ae3932bc492 61 fields · synced 22 Oct 2026
  • EUDAMED 07640158219607|B-07640158219607 61 fields · synced 19 May 2026
  • FDA UDI 231cb7f5-26f4-49da-bdac-47ba2ede1c60 36 fields · synced 30 May 2026