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ToRCH IgG/IgM Negative Control

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

Ref 105-024824-00Model 105-024824-00、105-024825-00、105-024826-00、105-024827-00

EMDN W0105080807

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000185P Basic UDI-DIDate9 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
105-024824-00、105-024825-00、105-024826-00、105-024827-00, 105-024824-00
Primary DI / UDI-DI
06903053020886
Basic UDI-DI
69449040AB74000185P
EMDN Code
W0105080807 Multiconstituent 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

Properties & raw data

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

Sources (1)

  • EUDAMED a9d600a0-c411-416d-90ea-15d0451405f9 61 fields · synced 22 Oct 2026