BMC G3 BPAP System - HSA Registration DE0507810
Access comprehensive regulatory information for BMC G3 BPAP System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507810 and owned by BMC Medical Co,. Ltd.. The device was registered on February 22, 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.
The G3 B20A / B25S / B25A / B25VT / B30VT BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The devices are intended for adult patients by prescription in the home or hospital/institutional environment. The G3 LAB BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation treatment and titration for patients with Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), Mixed Sleep Apnea (MSA), periodic breathing and Respiratory Insufficiency. The device is intended for adult patients by prescription in a clinical environment. The optional SpO2 kit used with the G3 BPAP Series together is indicated for monitoring patients’ SpO2 and Pulse Rate auxiliarily.