Edan SE-301 Electrocardiograph - HSA Registration DE0504930
Access comprehensive regulatory information for Edan SE-301 Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504930 and owned by Edan Instruments, Inc. The device was registered on September 16, 2020.
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.
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.