BIOTRONIK BIOMONITOR III - HSA Registration DE0505614
Access comprehensive regulatory information for BIOTRONIK BIOMONITOR III in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505614 and owned by BIOTRONIK SE & Co. KG. The device was registered on April 05, 2021.
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.
is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ECGs. Recording is activated both automatically and by the patient. The primary purpose is to provide early detection and diagnostics in the following clinical scenarios: - Clinical syndromes, which lead to an increased risk of cardiac rhythm disturbances - Temporary clinical symptoms, including dizziness, palpitations, syncope, or chest pain, which maybe the result of a cardiac rhythm disturbances - Evaluation of palpitations of unclear etiology - Recurrent syncope of unclear etiology - Confirmation or monitoring of atrial fibrillation - Clarification of a cryptogenic cerebrovascular stroke