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Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)

by Ningbo BESTest Bio-technology Co., Ltd. 2 variants

Ref DEN003-25, DEN003-05, BTT011-1, CR011Model 25 tests/kit, 5 tests/kit, 1 test/kit

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-000041242DEN003-256L Basic UDI-DI Date13 Jan 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-000041242DEN003-256L Basic UDI-DI Date13 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Trade Name
Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold)
Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)
Device Name
Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)
Model / Reference
25 tests/kit, DEN003-25, 5 tests/kit, DEN003-05, 1 test/kit, BTT011-1, CR011
Primary DI / UDI-DI
D-000041242DEN003-256L, D-000041242DEN003-056E, 06975496250052, D-CNMF000054349CR011G8
Basic UDI-DI
B-000041242DEN003-256L, B-000041242DEN003-056E, 697549625BTT011SF, B-CNMF000054349CR011G8
EMDN Code
W0105099007, W0105040611
Device Class
Class IVD General
Class C
EU market of registration
Germany
France

Manufacturer details

EUDAMED SRN
CN-MF-000041242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo BESTest Bio-technology Co., Ltd.

See all devices from Ningbo BESTest Bio-technology Co., Ltd. →

Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No