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Malaria Pathogen Nucleic Acid Detection Kit 2.1

by Shenzhen Chenghui Medical Technology Co., Ltd. China EUDAMED

Ref CHE-MLP4-201 EMDN W0105090401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975529960422 Basic UDI-DIDate28 Sep 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  • Withdrawn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 24 Oct 2026

Device Name
Malaria Pathogen Nucleic Acid Detection Kit 2.1
Model / Reference
CHE-MLP4-201
Primary DI / UDI-DI
06975529960422
Basic UDI-DI
B-06975529960422
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000046638
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Shenzhen Chenghui Medical Technology Co., Ltd.

See all devices from Shenzhen Chenghui Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED c366a029-0234-43ef-8a0a-f6f66e00a28a 61 fields · synced 24 Oct 2026