Masimo Radius PPG and Radius T° - HSA Registration DE0506859
Access comprehensive regulatory information for Masimo Radius PPG and Radius T° in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506859 and owned by Masimo Corporation. The device was registered on May 13, 2022.
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.
Masimo Radius PPG is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate. It is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) &pulse rate for use with adult, pediatric & neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities &home environments. Devices with Masimo technology are only to be used with Masimo sensors and cables. Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor(i.e. Masimo Root®, Masimo Rad-97).It is indicated for single-use, continuous body temperature measurements of persons 5years of age or older in hospitals, hospital-type facilities, &home environments.