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Malaria pf Rapid Test

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref IMA-402Model 25Tests/Kit

EMDN W0105050209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566303131 Basic UDI-DIDate9 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 25 Oct 2026

Model / Reference
25Tests/Kit, IMA-402
Primary DI / UDI-DI
06974566303131
Basic UDI-DI
B-06974566303131
EMDN Code
W0105050209 Plasmodium (malaria)
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

See all devices from Zhuhai Encode Medical Engineering 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 06974566303131|B-06974566303131 61 fields · synced 25 Oct 2026