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Dengue NS1 Antigen & IgG/IgM Combo Rapid Test Kit

by Beijing Diagreat Biotechnologies Co., Ltd. China EUDAMED

Ref G11813Model 25 tests/box

EMDN W0105040611

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697518250G1181336 Basic UDI-DIDate5 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
25 tests/box, G11813
Primary DI / UDI-DI
06942293580798
Basic UDI-DI
697518250G1181336
Direct Marketing DI
06942293580798
EMDN Code
W0105040611 Dengue virus
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019511
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Beijing Diagreat Biotechnologies Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reagent
  • Professional Testing
  • New Device
Other properties (7)
  • 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 537383bb-3bcb-4902-b131-65de863c9118 61 fields · synced 22 Oct 2026