BIOTRONIK Home Monitoring Service Center - HSA Registration DE0509259
Access comprehensive regulatory information for BIOTRONIK Home Monitoring Service Center in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509259 and owned by BIOTRONIK SE & Co. KG. The device was registered on May 07, 2024.
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 indications for using the Home Monitoring Service Center are the following: • The patient must be monitored in the post-operative phase. • The patient has a history of paroxysmal or intermittent atrial arrhythmias. • The patient has an exceptionally high incidence of ventricular tachycardia. • The patient has marginal sensing and/or pacing thresholds or lead impedances. • The patient's medication has changed. • The patient is unable to attend in-office follow-ups because the patient resides in a remote location or because the patient has transportation problems. • The device is nearing the end of its battery service time (ERI or EOS). • The use of remote monitoring is deemed necessary or advantageous by the physician. • The use of remote monitoring is suggested by the applicable guidelines.