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Malaria pf/pv Test Kit(Whole blood)

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

Ref MAL0041 EMDN W0105090499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-86979834610122 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  • Withdrawn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

Device Name
Malaria pf/pv Test Kit(Whole blood)MAL0041
Model / Reference
MAL0041
Primary DI / UDI-DI
86979834610122
Basic UDI-DI
B-86979834610122
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 a54c9f31-9172-4b07-bd13-37b2e56870da 61 fields · synced 22 Oct 2026