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Toxoplasma Gondii Antibody IgG (Toxo IgG) Reagent Kit (Chemiluminescent Immunoassay)

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref R18816Model 50 Tests/Kit

EMDN W0105050102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R188163Z Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Toxoplasma Gondii Antibody IgG (Toxo IgG) Reagent Kit (Chemiluminescent Immunoassay)
Model / Reference
50 Tests/Kit, R18816
Primary DI / UDI-DI
D-R188163Z
Basic UDI-DI
B-R188163Z
EMDN Code
W0105050102 Toxoplasma antibody igg
Device Class
Class IVD Annex II List B

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 648f76c2-ab29-4a4d-80b3-be8f745dc478 61 fields · synced 22 Oct 2026