Datascope CS100 & CS300 Intra-aortic Balloon Pumps and Accessories - HSA Registration DE0007551
Access comprehensive regulatory information for Datascope CS100 & CS300 Intra-aortic Balloon Pumps and Accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007551 and owned by Datascope Corp. The device was registered on September 20, 2011.
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 balloon pump is an electomechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.