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Masimo Rad-G™ Pulse Oximeter - HSA Registration DE0505660

Access comprehensive regulatory information for Masimo Rad-G™ Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505660 and owned by Masimo Corporation. The device was registered on April 16, 2021.

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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CLASS C
DE0505660
Masimo Rad-G™ Pulse Oximeter
HSA Registration Number: DE0505660
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Product Description

The Rad-G™ Pulse Oximeter is intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G Pulse Oximeter and Accessories are indicated for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PRof adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. The Rad-G Pulse Oximeter and Accessories are indicated for the noninvasive spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505660
Registration Date
April 16, 2021
Retention Due Date
April 15, 2026
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)
Rad-G SpO2 Reusable Finger Clip Sensor Rad-G YI SpO2 Multisite Reusable Sensor Rad-G™ Pulse Oximeter Rad-G™ Pulse Oximeter
Model Identifier(s)
4325 4653 9847 9849