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Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC)

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10995601Model IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901896WR Basic UDI-DIDate11 Jun 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  • Withdrawn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
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, 10995601
Primary DI / UDI-DI
00630414599243
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

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Properties

  • 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