BMC PolyWatch Portable Sleep Systems - HSA Registration DE0509053
Access comprehensive regulatory information for BMC PolyWatch Portable Sleep Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509053 and owned by BMC Medical Co., Ltd.. The device was registered on March 13, 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.
Sleep Apnea Diagnosis Device records the sleep data, for the purpose to diagnose of sleep disordered breathing. YH-600A Pro records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and wrist movement during sleep. It can also be connected to a CPAP system to record and display continuous positive airway pressure. The device uses these recordings to produce a report that may aid in the screening of sleep disordered breathing or for further clinical investigation. The device is intended for the hospital / institutional environment (supervised) and the home environment (unsupervised) for adults. YH-600B Pro records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position and wrist movement during sleep.