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Dengue IgM/IgG test cassette

by Nantong EgensBiotechnology Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref Dengue-IgM/IgG 252102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757992101PU 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  • Withdrawn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European Union — CE/IVDD Withdrawn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

Model / Reference
Dengue-IgM/IgG 252102
Primary DI / UDI-DI
D-693757992101PU
Basic UDI-DI
B-693757992101PU
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.

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Properties

Show properties
  • 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