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Malaria Test Device(whole blood)

by Neo-nostics (Suzhou) Bioengineering Co., Ltd. China EUDAMED

Ref MAL0238 EMDN W0105090499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-86979834610313 Basic UDI-DIDate25 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  • Withdrawn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 22 Oct 2026

Model / Reference
MAL0238
Primary DI / UDI-DI
86979834610313
Basic UDI-DI
B-86979834610313
EMDN Code
W0105090499 Parasites - rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000013087
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd.

See all devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 0ecd62e3-f904-43ae-adf8-46d5d9d7b7b1 61 fields · synced 22 Oct 2026