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Siemens PRISCA 5 Software - HSA Registration DE0509143

Access comprehensive regulatory information for Siemens PRISCA 5 Software in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509143 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on April 08, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C IVD
DE0509143
Siemens PRISCA 5 Software
HSA Registration Number: DE0509143
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Product 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 operatorโ€™s guide provides information for the laboratory professionals who use the system.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509143
Registration Date
April 08, 2024
Retention Due Date
April 07, 2026
Product Owner
Short Name
Siemens Healthcare Diagnostics Products Limited
Address
Gly Rhonwy, Llanberis, Gwynedd LL55 4EL, UNITED KINGDOM
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
PRISCA 5 Software
Model Identifier(s)
10475998