Australia TGA ARTG recordMarker, lesion localization, implantable
Australia TGA ARTG Registered Device · BIOS Healthcare · BIP Biomedizinische Instrumente und Produkte GmbH · Class IIb · Started August 04, 2022
Good Name: BIOS Healthcare - Marker, lesion localization, implantable
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 04, 2022
- Effective Date
- August 04, 2022
- Name
- BIOS Healthcare
- Country
- Germany
- Address
- Am Brand 1, Turkenfeld, 82299
The implantable clip is intended for marking soft tissue for monitoring of lesions after biopsies, before or during chemotherapy and in radiotherapy treatment planning. It is intended for single-use and for long-term application. Indications are anomalies in breast tissue including axillary lymph nodes.
Access comprehensive regulatory information for Marker, lesion localization, implantable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by BIOS Healthcare, manufactured by BIP Biomedizinische Instrumente und Produkte GmbH in Germany. The device registration started on August 04, 2022.
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.