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HIV (1+2) Antibody Rapid Test

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

Active European Union

Ref HIV3-29200111000Model HIV3-29204017000

Regulatory status

as of 27 Oct 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
HIV (1+2) Antibody Rapid Test
Model / Reference
HIV3-29204017000, HIV3-29200111000
Primary DI / UDI-DI
06940131404985
Basic UDI-DI
69401314HIV002CG
Direct Marketing DI
06940131404985
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

  • 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