Sigknow EZYPRO ECG Recorder UG02 - HSA Registration DE0507636
Access comprehensive regulatory information for Sigknow EZYPRO ECG Recorder UG02 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507636 and owned by Sigknow Biomedical Co. Ltd.. The device was registered on December 23, 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.
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 18 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection. During wearing, EZYPRO ECG Recorder (Model: UG02) can transfer ECG data digitally via Bluetooth technology to the mobile device embedded the APP (EZY iSee) which shows up the measuring status in real-time basis. EZY iSee does not contain diagnostic interpretation. UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data