Respironics Trilogy Evo EV300 - HSA Registration DE0505987
Access comprehensive regulatory information for Respironics Trilogy Evo EV300 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505987 and owned by Respironics, Inc.. The device was registered on July 15, 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.
The Trilogy EV300 ventilator is to provide continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The Trilogy EV300 is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and noninvasive ventilation. The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency and Respiratory Failure