BIOTRONIK Renamic Neo Medical Programmer and Monitoring Device - HSA Registration DE0507259
Access comprehensive regulatory information for BIOTRONIK Renamic Neo Medical Programmer and Monitoring Device in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507259 and owned by BIOTRONIK SE & Co. KG. The device was registered on September 14, 2022.
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 programmer provides communication with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs) during the implantation procedure or patient follow-up. The programmer is intended to enable the intended use of the implantable products by supplying the user interface to the device functions. Therefore, the programmer is used: to verify and optimize the therapy delivered by the devices; to support diagnosis of the patient status through data delivered by the devices. The PSA (pacing system analyzer) of the programmer supports lead implantations during the implantation procedure. Therefore, the PSA is used: to support lead implantations with intraoperative measurements of electrophysiological parameters.