Singapore HSA registration DE0506859
Masimo Radius PPG and Radius T°
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506859
- Registration Date
- May 13, 2022
- Change Notification Approval Date
- January 16, 2023
- Retention Due Date
- May 12, 2025
Product description
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.
Product Owner
- Short Name
- Masimo Corporation
- Address
- 52 Discovery, CA 92618, UNITED STATES
Registrant
- Address
- 31 UBI ROAD 1, #04-05, SINGAPORE 408694
Importer
- Address
- 31 UBI ROAD 1, #04-05, SINGAPORE 408694
Model information
- Model Name(s)
- Radius PPG and Radius T° for Masimo SafetyNet
- Model Identifier(s)
- 4778
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C