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ADVIA Centaur HBeAg (HBe) Quality Control

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10291296Model IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC

EMDN W0105080802

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901896WR Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

IcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

EU market availability

Available in 32 countries, as listed in EUDAMED:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC
Model / Reference
IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC, 10291296
Primary DI / UDI-DI
00630414510668
Basic UDI-DI
0405686901896WR
EMDN Code
W0105080802 Hepatitis virus controls - inf.imm.
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
  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f02e66cd-a8b7-4aa1-ab53-21db345a0592 61 fields · synced 24 Oct 2026