Siemens RAPIDPoint® 500 Systems - HSA Registration DE0013267
Access comprehensive regulatory information for Siemens RAPIDPoint® 500 Systems 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 DE0013267 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on June 28, 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.
The RAPIDPoint 500 systems are intended for in vitro diagnostic use and are designed to provide the determination in whole blood for the following parameters: Partial pressure of carbon dioxide, Partial pressure of oxygen, pH, Sodium, Potassium, Ionized calcium, Chloride, Glucose, Total hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb, Neonatal bilirubin and Lactate. RAPIDPoint 500 systems are also intended for in vitro testing of pleural fluid samples for the pH parameter and the measurement of Na+, K+, Ca++, Cl- in dialysate fluid. These test systems are intended for use in point-of-care or laboratory settings.