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Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)

by Avioq Bio-tech Co., Ltd. China EUDAMED

Ref 40 Tests/Kit EMDN W0105090401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975166201377 Basic UDI-DIDate15 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  • Withdrawn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 25 Oct 2026

Device Name
Malaria Pf/Pan Antigen Assay Kit(Colloidal gold)
Model / Reference
40 Tests/Kit
Primary DI / UDI-DI
06975166201377
Basic UDI-DI
B-06975166201377
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048146
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Avioq Bio-tech Co., Ltd.

See all devices from Avioq Bio-tech 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 cf52df13-c4c8-4941-aeeb-69ac6fa0a59b 61 fields · synced 25 Oct 2026