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ADVIA Centaur Hepatitis B e Antigen

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10291295Model IVDR_67_TTN_DUB-C_D_KIT_HBeAg

EMDN W0105020211

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901880WA Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Device Name
IVDR_67_TTN_DUB-C_D_KIT_HBeAg
Model / Reference
IVDR_67_TTN_DUB-C_D_KIT_HBeAg, 10291295
Primary DI / UDI-DI
00630414510651
Basic UDI-DI
0405686901880WA
EMDN Code
W0105020211 Hepatitis b antigen
Device Class
Class D
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • 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

Sources (1)

  • EUDAMED 00630414510651|0405686901880WA 61 fields · synced 25 Oct 2026