BIOTRONIK BIOMONITOR IIIm - HSA Registration DE0507418
Access comprehensive regulatory information for BIOTRONIK BIOMONITOR IIIm in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507418 and owned by BIOTRONIK SE & Co. KG. The device was registered on October 28, 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.
BIOMONITOR IIIm is an implantable cardiac rhythm monitoring system that records subcutaneous ECGs. Recording is activated both automatically and by the patient. The cardiac monitor does not have any therapeutic function. Generally approved differential diagnostic methods, as well as the indications and recommendations for the medical use of implantable cardiac monitors apply to BIOMONITOR IIIm. 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 may be 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