MAQUET CARDIOHELP System - HSA Registration DE0016399
Access comprehensive regulatory information for MAQUET CARDIOHELP System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0016399 and owned by Maquet Cardiopulmonary GmbH. The device was registered on October 09, 2014.
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 CARDIOHELP system is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support. The support system is generally suitable for all types of applications as: Circulatory support through to recovery, or the temporary bridging of therapeutic measures through to recovery and weaning off the support system; Bridging through to explantation/transplantation; Temporary bridging through to further therapeutic methods or further decisions; Circulatory support to permit further therapeutic and surgical procedures. The CARDIOHELP system is designed for intra-hospital and inter-hospital patient transport and for continuous operation. The maximum duration of use is 30 days if BIOLINE-coated HLS cannulae from MAQUET are used. If cannulae from other manufacturers are used, the maximum duration of use for the HLS Set is 6 hours.