BMC Polypro Portable Sleep Diagnostic System and Polysomnograph - HSA Registration DE0510190
Access comprehensive regulatory information for BMC Polypro Portable Sleep Diagnostic System and Polysomnograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510190 and owned by BMC Medical Co., Ltd.. The device was registered on December 31, 2024.
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.
H2 records the following data: patient respiratory airflow, snoring, blood oxygen saturation, pulse, respiratory effort, and body position during sleep. H2 plus can additionally be used for ECG recording and H2 Elite & H2 Pro can additionally be used for recording EEG, EOG, ECG, EMG during sleep. It can also be connected to a CPAP / Auto CPAP / BPAP system through the pressure monitoring port of mask to record and display continuous positive airway pressure. The device uses these recordings to produce a report that may aid in the diagnosis of sleep-disordered breathing or for further clinical investigation. The devices are intended for the hospital / institutional environment (supervised) for adults.