Medical Wearable Platform SDK-01 - HSA Registration DE0509109
Access comprehensive regulatory information for Medical Wearable Platform SDK-01 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509109 and owned by VivaLNK, INC.. The device was registered on March 26, 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.
Medical Wearable Platform SDK-01 is intended to record, store and transfer electrocardiogram (ECG) and accelerometer data. The platform has the capability to provide Heart Rate, Respiratory Rate (RR), R-R Interval and Blood Pressure values. The ECG recorder Patch is an ambulatory, continuous recording Patch, intended for at home or hospital use, by clinicians or health professionals who intend to monitor their patient's physiological and health conditions for an extended period of time.