Cardioline S.P.A ECG200+ - HSA Registration DE0508670
Access comprehensive regulatory information for Cardioline S.P.A ECG200+ in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508670 and owned by Cardioline S.p.a.. The device was registered on November 17, 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.
The Device is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via Internet or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. The device is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.