Bio-Beat Biobeat Medical Smartmonitoring - HSA Registration DE0507343
Access comprehensive regulatory information for Bio-Beat Biobeat Medical Smartmonitoring in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507343 and owned by Bio-Beat Technologies Ltd.. The device was registered on October 04, 2022.
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.
BB-613WP is indicated for measurement, spot- checking monitoring, displaying, and storage of biophysical parameters as an adjunct in the assessment of cardiovascular and respiratory status. Indications for use: Blood oxygen saturation, pulse rate, non-invasive blood pressure, cardiac output, stroke volume, respiratory rate, skin temperature, one lead EKG (patch only), mean arterial pressure, pulse pressure, systemic vascular resistance, cardiac index, and pulse rate variability. To be used in healthcare facilities by clinical professionals or under their guidance, or in patient’s home under clinician’s guidance. It is NOT designed to be used in life support situations. BB-613W/P is indicated for adult (+18) patients in hospitals, clinics, long-term care, and home use. BB-613P is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. BB-613P ECG is not intended for automated diagnosis.