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Atellica IM VitDII Quality Control (VitDII QC)

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 11698632Model IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686902371VP Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC
Model / Reference
IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC, 11698632
Primary DI / UDI-DI
00630414649887
Basic UDI-DI
0405686902371VP
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class B
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
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No