Singapore HSA registration DE0509143
Siemens PRISCA 5 Software
Singapore·CLASS C IVD·Siemens Healthcare Diagnostics Products Limited·Registered April 08, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD