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Malaria Antibody Rapid Test Kit (Colloidal gold method)

by Synthgene (Yixing) Health Technology Co., Ltd. China EUDAMED

Ref CR046 EMDN W0105050209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000054349CR046GT Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
CR046
Primary DI / UDI-DI
D-CNMF000054349CR046GT
Basic UDI-DI
B-CNMF000054349CR046GT
EMDN Code
W0105050209 Plasmodium (malaria)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000054349
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Synthgene (Yixing) Health Technology Co., Ltd.

See all devices from Synthgene (Yixing) Health Technology Co., Ltd. →

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 c16f0c04-7c49-4aa9-a6f7-74b4a80f229c 61 fields · synced 25 Oct 2026