Singapore HSA registration DE0506258
Masimo Radical-7 Pulse CO-Oximeter
Singapore·CLASS C·Masimo Corporation·Registered October 06, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506258
- Registration Date
- October 06, 2021
- Change Notification Approval Date
- November 07, 2022
- Retention Due Date
- October 05, 2025
Product description
The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. The Masimo Radical-7 Pulse CO-Oximeter may be provided with the oxygen reserve index (ORi) as an adjunct to standard pulse oximetry monitoring. ORi is a trend index that extends oxygen monitoring to patients on supplemental oxygen in adult and pediatric patients.
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)
- Rainbow DCI SC1000 Rainbow DCIP SC 1000 Rainbow DCI-6 Rainbow DCIP-6 RD SET Blue RD SET™ E1® RD SET™ TFA-1® RD rainbow Adt 8λ SpCO RD rainbow Pdt 8λ SpCO RD rainbow Inf 8λ SpCO RD rainbow Neo 8λ SpCO RD SET™ DBI LNCS-II rainbow DCI 8λ SpHb SC 200 LNCS-II rainbow DCI 8λ SpHb SC 400 LNCS-II rainbow DCI 8λ SpHb SC 1000 LNCS-II rainbow DCIP 8λ SpHb SC 200 LNCS-II rainbow DCIP 8λ SpHb SC 400 LNCS-II rainbow DCIP 8λ SpHb SC 1000 LNCS-II rainbow DCI 8λ SpCO LNCS-II rainbow DCIP 8λ SpCO LNCS-II rainbow DCI-6 8λ SpCO LNCS-II rainbow DCIP-6 8λ SpCO RAS-45 Inf/Neo RD SET™ Adt cs-2 RD SET™ Pdt cs-2 RD SET™ Inf cs-2 RD SET™ Neo cs-2 RD SET™ NeoPt cs-2 RD SET™ Adt cs-3 RD SET™ Pdt cs-3 RD SET™ Inf cs-3 RD SET™ Neo cs-3 RD SET™ NeoPt cs-3 Radical Docking Station Radical Docking Station Radical-7 Pulse CO-Oximeter Root
- Model Identifier(s)
- 3647 3648 3657 3658 4014 4015 4016 4034 4035 4036 4037 4052 4058 4059 4060 4061 4062 4063 4067 4068 4069 4070 4425 4470 4471 4472 4473 4474 4475 4476 4477 4478 4479 9021 9023 9500 9515
About this record
Access comprehensive regulatory information for Masimo Radical-7 Pulse CO-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 DE0506258 and owned by Masimo Corporation. The device was registered on October 06, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C