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HSA · registration DE0509143

Siemens PRISCA 5 Software

SingaporeImmunologyClass CSiemens Healthcare Diagnostics Products Limited
Verified
Official record identity
Registration number
DE0509143
Model name
PRISCA 5 Software
Model identifier
10475998
Registration date
April 08, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Immunology
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Published parties
Product owner
Siemens Healthcare Diagnostics Products Limited
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

Software to calculate risk of Trisomy 21, Trisomy 18, Trisomy 13, Neural Tube Defects, and the ability to share and control immunoassay medians. PRISCA is for professional use only. The operator’s guide provides information for the laboratory professionals who use the system.

Additional source fields
Product owner address
Gly Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
Registrant address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.