BIOTRONIK ENITRA PACEMAKERS - HSA Registration DE0504686
Access comprehensive regulatory information for BIOTRONIK ENITRA PACEMAKERS in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504686 and owned by BIOTRONIK SE & Co. KG. The device was registered on July 13, 2020.
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.
Enitra is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: (1) Compensation of bradycardia by atrial, ventricular, or AV sequential pacing. (2) Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacing.