Edan Instruments RespArray™ Patient Monitor - HSA Registration DE0510397
Access comprehensive regulatory information for Edan Instruments RespArray™ Patient 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 DE0510397 and owned by Edan Instruments, Inc.. The device was registered on February 27, 2025.
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.
The RespArray™ patient monitor is intended to be used for monitoring, storing, reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates for use by trained healthcare professionals in hospital environments for prescription use only. The monitored physiological parameters include ECG, RESP,TEMP, SpO2, PR, NIBP, and CO2. The arrhythmia detection and ST Segment analysis are intended for adult patients. The SpO2 Nellcor module is intended to be used for spot-check or continuous non-invasive monitoring of functional SpO2 and PR, in motion and no motion conditions, and in patients who are well or poorly perfused. The Microstream capnography module is intended for continuous non- invasive monitoring of etCO2 and RR monitor also provides the clinician with IPI, A/hr and ODI values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up. The monitors are not intended for MRI environments.