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Toxo IgG Avidity Control

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref 105-029876-00Model 105-029863-00、105-029867-00、105-029872-00、105-029873-00、105-029874-00、105-029875-00、105-029876-00、105-029877-00、105-029878-00、105-029879-00 EMDN W0105080805

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000255L Basic UDI-DIDate31 Jan 2024RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Toxoplasma gondii IgG Avidity（CLIA）、Toxo IgG Avidity Control
Model / Reference
105-029863-00、105-029867-00、105-029872-00、105-029873-00、105-029874-00、105-029875-00、105-029876-00、105-029877-00、105-029878-00、105-029879-00, 105-029876-00
Primary DI / UDI-DI
06903053059992
Basic UDI-DI
69449040AB74000255L
Direct Marketing DI
06903053059992
EMDN Code
W0105080805 Parasitology controls - inf.imm.
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 750385dd-062f-42e4-8c96-b9fb0d24dc83 61 fields · synced 24 Oct 2026