OSATU Reanibex 500 Monitor Defibrillator - HSA Registration DE0018394
Access comprehensive regulatory information for OSATU Reanibex 500 Monitor Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018394 and owned by OSATU S.Coop. The device was registered on July 21, 2016.
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 REANIBEX 500 is a portable, lightweight Monitor/Defibrillator designed to carry out advanced monitoring and resuscitation functions. It offers four operating modes: Monitor, Manual Defibrillator, Automated Defibrillator and Non-Invasive Transcutaneous Pacemaker (optional). The REANIBEX 500 should be used by medical personnel trained in the use of the device. These personnel should also be trained and qualified in basic life support, advanced life support or defibrillation in a hospital or out-of-hospital environments that complies with the environmental characteristics indicated in the guide. Both the Automated and Manual defibrillator mode can be used with standard defibrillation electrodes only in adults and in children over 8 years of age or weighing over 25 kg (55 lbs). Both the Automated and Manual defibrillator mode can be used in children under 8 years of age or weighing less than 25 kg (55 lbs) with specific paediatric defibrillation electrodes.