Xenios Xenios therapy system - HSA Registration DE0508730
Access comprehensive regulatory information for Xenios Xenios therapy system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508730 and owned by Xenios AG. The device was registered on December 05, 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 Xenios therapy system is used to pump blood in extracorporeal circuits. Typical fields of therapy include: • temporary cardiovascular support during and after surgical interventions • provision of temporary cardiopulmonary support for the stabilization or treatment of patients. The pump head is generally indicated for use for neonatal, pediatric and adult patients • With cardiac and/or respiratory failure (duration of use of up to 29 days) • With cardiac failure requiring a cardiopulmonary bypass (duration of use of ≤ 6 hours) The pump head is also indicated for use in adult patients in cardiogenic shock or requiring high- risk percutaneous coronary intervention (PCI) (duration of use of ≤ 7 days). The pump head is furthermore indicated for use in the bridging to transplantation of isolated organs.