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Abon™

by Abon Biopharm(Hangzhou) Co., Ltd China EUDAMED

Ref IHBsg-402001 EMDN W0105090201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69529994HBV0001X4 Basic UDI-DIDate22 Jun 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Device Name
ABON™ HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)
Model / Reference
IHBsg-402001
Primary DI / UDI-DI
06952999410008
Basic UDI-DI
69529994HBV0001X4
EMDN Code
W0105090201 Hbsag - rt & poc
Device Class
Class D

Manufacturer details

EUDAMED SRN
CN-MF-000009171
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Abon Biopharm(Hangzhou) Co., Ltd

See all devices from Abon Biopharm(Hangzhou) Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06952999410008|69529994HBV0001X4 61 fields · synced 25 Oct 2026