Singapore HSA registration DE0508734
Masimo Radius VSM Patient-Worn Vital Signs Monitor
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0508734
- Registration Date
- December 07, 2023
- Retention Due Date
- December 06, 2025
Product description
Radius VSM is intended for use as both wearable multi-parameter patient monitor and accessory to a multi-parameter patient monitor intended for physiological patient monitoring in hospitals, healthcare facilities and home. Radius VSM is indicated for monitoring hemodynamic (including ECG, arrhythmia detection, NiBP, SpO2, Pulse Rate, PVi, heart rate and temperature), and respiratory (e.g. impedance, acoustic, pleth-based respiration rate) physiological parameters along with orientation and activity of adults. Radius VSM is indicated for the non-invasive continuous monitoring of SpO2 and PR for well or poorly perfused adults during no motion and motion conditions, monitoring of body temperature, orientation and activity of patients including those susceptible to pressure ulcers, and PVi as a measure of relative variability of photoplethysmograph (pleth) during no motion conditions. PVi may be used as a dynamic indicator of fluid responsiveness in select mechanically ventilated patients.
Product Owner
- Short Name
- Masimo Corporation
- Address
- 52 Discovery, Irvine, 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 VSM Root Charger Radius VSM RAS-45 RRa Adult Acoustic Respiration Sensor Radius VSM Multi-functional Reusable Pod Radius VSM NIBP Module Radius VSM Kit with Reusable Pod & NIBP Radius VSM Patient-Worn Vital Signs Monitor
- Model Identifier(s)
- 4784 4828 4888 4889 9036 9037
About this record
Access comprehensive regulatory information for Masimo Radius VSM Patient-Worn Vital Signs Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508734 and owned by Masimo Corporation. The device was registered on December 07, 2023.
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