Singapore HSA registration DE0012195
Siemens ADVIA Chemistry 1800, 2400, XPT Creatinine_2 (CREA_2)
Singapore·CLASS B IVD·Simens Healthcare Diagnostics Inc.·Registered January 17, 2013Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0012195
- Registration Date
- January 17, 2013
- Change Notification Approval Date
- August 23, 2018
- Retention Due Date
- January 16, 2026
Product description
For in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine on ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
Product Owner
- Short Name
- Siemens Health
- Address
- 511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
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)
- ADVIA Chemistry Creatinine_2 (CREA_2) Siemens Chemistry Calibrator
- Model Identifier(s)
- 03039070 09784096 (PN T03-1291-62)
About this record
Access comprehensive regulatory information for Siemens ADVIA Chemistry 1800, 2400, XPT Creatinine_2 (CREA_2) 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 DE0012195 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on January 17, 2013.
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