Singapore HSA registration DE0509723
ProciseDx ProciseDx Analyzer
Singapore·CLASS B IVD·ProciseDx Inc.·Registered September 03, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509723
- Registration Date
- September 03, 2024
- Change Notification Approval Date
- September 11, 2024
- Retention Due Date
- September 02, 2025
Product description
The ProciseDx instrument is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The platform should be used in accordance with user documentation and facility specific regulations. The ProciseDx System is designed to be used at the point-of-care, clinical laboratory, hospital laboratory, or near patient laboratory settings.
Product Owner
- Name
- ProciseDx Inc.
- Short Name
- ProciseDx Inc.
- Address
- 9449 Carroll Park DR, San Diego, CA, 92121 USA, UNITED STATES
Registrant
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
- Model Name(s)
- ProciseDx Analyzer ProciseDx Calibration Cartridge Procise FCP Assay Method File (AMF)
- Model Identifier(s)
- 4390 4759 Procise FCP Assay Method File (AMF)
About this record
Access comprehensive regulatory information for ProciseDx ProciseDx Analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509723 and owned by ProciseDx Inc.. The device was registered on September 03, 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 B IVD