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Biotronik SE & Co KG

Manufacturer • Germany · 211 devices on the TGA ARTG · 6 device classes · Jan 30, 2007 – Apr 16, 2024

211
Total Devices
6
Device Classes
2007
Earliest
2024
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
BIOMONITOR IV - Implantable cardiac monitor
ARTG 445773
Class IIIApr 16, 2024
Sponsor: Biotronik Australia Pty Ltd
BIOMONITOR IV - Implantable cardiac monitor
Class IIIApr 16, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky SR-T - Single-chamber pacemaker, rate-responsive
ARTG 443694
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Solvia Rise DR-T - Dual-chamber pacemaker, rate-responsive
ARTG 443693
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky HF-T QP - Biventricular pacemaker
ARTG 443691
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Solvia Rise SR-T - Single-chamber pacemaker, rate-responsive
ARTG 443692
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky DR-T - Dual-chamber pacemaker, rate-responsive
ARTG 443695
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky DR-T - Dual-chamber pacemaker, rate-responsive
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky HF-T - Biventricular pacemaker
ARTG 443690
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
Amvia Sky HF-T - Biventricular pacemaker
Class IIIMar 13, 2024
Sponsor: Biotronik Australia Pty Ltd
View All 211 Devices →
Risk class distribution
Devices by risk class
Class I
16
7.6% of total
Class IIa
4
1.9% of total
Class IIb
16
7.6% of total
Class III
129
61.1% of total
Class Is
16
7.6% of total
AIMD
30
14.2% of total
About this profile

Explore comprehensive manufacturer profile for Biotronik SE & Co KG through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 211 medical devices registered with TGA ARTG across 6 device classes. This manufacturer is based in Germany. Their registration history spans from Jan 30, 2007 to Apr 16, 2024.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIb: 16, Class I: 16, Class III: 129, Class Is: 16, Class IIa: 4, AIMD: 30), and complete regulatory information 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.

Free Manufacturer ProfilePowered by Pure Global AI211 Devices6 Device Classes