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Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref SAC2022011Model 10 tests/kit

EMDN W0105090401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SAC2022011E3 Basic UDI-DIDate13 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test (Colloidal Gold)
Model / Reference
10 tests/kit, SAC2022011
Primary DI / UDI-DI
D-SAC2022011E3
Basic UDI-DI
B-SAC2022011E3
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f9ff0973-12be-4f31-a36e-60f629f7448c 61 fields · synced 23 Oct 2026