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HIV (1+2) Antibody Rapid Test

by NewScen Coast Bio-Pharmaceutical Co., Ltd. China EUDAMED

Ref HIV3-29202511000Model HIV3-29204017000

EMDN W0105090302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69401314HIV002CG Basic UDI-DIDate24 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaDenmarkNetherlandsGermanyGermanyPolandPolandFranceLuxembourgPolandFranceFranceHungaryFranceFrancePortugalSpainSpainItalySpainSpainGreece
  • Active
  • Not covered

European Union — CE/IVDR Active

EU market availability

Available in 14 countries, as listed in EUDAMED:

  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HIV (1+2) Antibody Rapid Test
Model / Reference
HIV3-29204017000, HIV3-29202511000
Primary DI / UDI-DI
06940131404992
Basic UDI-DI
69401314HIV002CG
Direct Marketing DI
06940131404992
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class D
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000021934
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from NewScen Coast Bio-Pharmaceutical Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a54c01d4-bb1a-4d34-838c-6d5aed1f8dca 61 fields · synced 24 Oct 2026