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ADVIA Centaur Pregnancy-Associated Plasma Protein-A (PAPP-A)

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10995000Model IVDR_67_TTN_DUB-C_C_KIT_Pregnancy-Assoc Plasma Protein-A

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901819W7 Basic UDI-DIDate8 Sep 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  • Withdrawn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_C_KIT_Pregnancy-Assoc Plasma Protein-A
Model / Reference
IVDR_67_TTN_DUB-C_C_KIT_Pregnancy-Assoc Plasma Protein-A, 10995000
Primary DI / UDI-DI
00630414603353
Basic UDI-DI
0405686901819W7
EMDN Code
W0102050210 Pregnancy associated plasma protein - a (downs)
Device Class
Class C
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
  • Professional Testing

Other properties (8)

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