ARTG 445773BIOMONITOR IV - Implantable cardiac monitor
ARTG ID: 445773 · Biotronik Australia Pty Ltd · Biotronik SE & Co KG · Class III · Started April 16, 2024
Good Name: Biotronik Australia Pty Ltd - BIOMONITOR IV - Implantable cardiac monitor
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 445773
- Start Date
- April 16, 2024
- Effective Date
- April 16, 2024
- Country
- Germany
- Address
- Woermannkehre 1, Berlin, D-12359
BIOMONITOR IV is an implantable cardiac monitor intended to: - Detect cardiac rhythm disturbances and monitor their occurrence and frequency in diseases involving brady/tachyarrhythmias, asystoles, sudden cardiac rate drops, as well as rhythm recordings triggered by the patient experiencing symptoms - Monitor patient activity and body temperature trend The implantable cardiac monitor achieves its intended purpose by detection, analysing and subsequent recording of subcutaneous ECGs and additional long-term diagnostic data.
Access comprehensive regulatory information for BIOMONITOR IV - Implantable cardiac monitor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 445773 and sponsored by Biotronik Australia Pty Ltd, manufactured by Biotronik SE & Co KG in Germany. The device registration started on April 16, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.