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Malaria Pf/PAN Test

by Abiores Technology (Beijing) Co., Ltd. EUDAMED

Active European Union

Ref AB43-21Model Strip & Cassette

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06958982140280 Basic UDI-DIDate28 Jul 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  • Withdrawn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

Model / Reference
Strip & Cassette, AB43-21
Primary DI / UDI-DI
06958982140280
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000022952
Authorised representative
Sungo Cert GmbH DE-AR-000010869

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