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Real-time PCR Detection Kit for Plasmodium Falciparum

by Beijing Applied Biological Technologies Co., Ltd. China EUDAMED

Ref ID045 EMDN W0104050202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974323010982 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  • Withdrawn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
Real-time PCR Detection Kit for Plasmodium Falciparum
Model / Reference
ID045
Primary DI / UDI-DI
06974323010982, 06974323010975
Basic UDI-DI
B-06974323010982, B-06974323010975
EMDN Code
W0104050202 Plasmodium falciparum
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012338
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Beijing Applied Biological Technologies Co., Ltd.

See all devices from Beijing Applied Biological Technologies 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 (2)

  • EUDAMED 6d528b7f-2124-4128-b22b-7b1f3d31e23b 61 fields · synced 22 Oct 2026
  • EUDAMED 06974323010975|B-06974323010975 61 fields · synced 22 Jul 2026