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Atellica IM Pregnancy-Associated Plasma Protein-A (PAPP-A)

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10733019Model IVDR_67_TTN_DUB-C_C_KIT_Pregnancy-Assoc Plasma Protein-A

EMDN W0102050210

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901819W7 Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

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, 10733019
Primary DI / UDI-DI
00630414245904
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

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
  • 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

Sources (1)

  • EUDAMED 00630414245904|0405686901819W7 61 fields · synced 24 Oct 2026