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Atellica IM Free Prostate-Specific Antigen Calibrator (fPSA CAL)

by Siemens Healthcare Diagnostics Products Ltd. EUDAMED

Active European Union

Ref 11203743Model IVDR_67_LLB_DUB-C_C_REAG_fPSA CAL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901479W5 Basic UDI-DIDate14 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  • Withdrawn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_LLB_DUB-C_C_REAG_fPSA CAL
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_fPSA CAL, 11203743
Primary DI / UDI-DI
00630414290577
Basic UDI-DI
0405686901479W5
EMDN Code
W0102152205 Tumour marker standards and calibrators
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016339
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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