Singapore HSA registration DE0506859

Masimo Radius PPG and Radius T°

Singapore flagSingapore·CLASS C·Masimo Corporation·Registered May 13, 2022
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.

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