Cardioline® TouchECG System - HSA Registration DE0508498
Access comprehensive regulatory information for Cardioline® TouchECG System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508498 and owned by Cardioline S.p.a.. The device was registered on September 20, 2023.
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.
TouchECG System is intended for the acquisition of resting ECG exams to check and diagnose cardiac functions. However, a physician must validate the results of the analysis performed by the ECG device. It is intended for analysing ECG signals, acquired and transmitted with the HD+ acquisition device (HD + / CLICKECG‐HD, HD+ 12 / CLICKECG‐HD 12, HD+ 15 / CLICKECG‐HD 15). TouchECG System is intended for use in hospitals, clinics and outpatient departments of any size. It is suitable for use by health workers. The analysis of ECG traces and the automatic interpretation must always be validated by a physician. The device can't diagnose the patient condition by itself, but only display the results of the ECG interpretation according to Glasgow Resting ECG Analysis program.