Skip to content

Dengue NS1 antigen test cassette

by Nantong EgensBiotechnology Co., Ltd. China EUDAMED

Ref Dengue-NS1 252102 EMDN W0105040611

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757992102PW Basic UDI-DIDate14 Nov 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Dengue-NS1 252102
Primary DI / UDI-DI
D-693757992102PW
Basic UDI-DI
B-693757992102PW
EMDN Code
W0105040611 Dengue virus
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000021561
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Nantong EgensBiotechnology Co., Ltd.

See all devices from Nantong EgensBiotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • 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

Sources (1)

  • EUDAMED 080b52b6-9b8e-4e62-b28a-32cdd827783d 61 fields · synced 24 Oct 2026