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MALARYA Pf/Pv/Pan HIZLI TEST KİTİ

by Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref VISD045

EMDN W0105090401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868382945VISD0459C Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
MALARIA Pf/Pv/Pan RAPID TEST KIT
Model / Reference
VISD045
Primary DI / UDI-DI
08683829450496
Basic UDI-DI
868382945VISD0459C
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024208

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED 08683829450496|868382945VISD0459C 61 fields · synced 23 Oct 2026