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EasyNAT Malaria Assay

by Ustar Biotechnologies (Hangzhou) Ltd. EUDAMED

Active European Union

Ref U203010-20

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973492240374 Basic UDI-DIDate8 Jan 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
EasyNAT Malaria Assay
Model / Reference
U203010-20
Primary DI / UDI-DI
06973492240374
Basic UDI-DI
B-06973492240374
EMDN Code
W0105050209 Plasmodium (malaria)
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000014615
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ustar Biotechnologies (Hangzhou) Ltd.

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Properties

  • 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