Pure Global

Marker, lesion localization, implantable

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.

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Class IIb
Class IIb
Marker, lesion localization, implantable
Australia TGA ARTG Registered Device
Good Name: BIOS Healthcare - Marker, lesion localization, implantable
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Intended Purpose

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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 04, 2022
Effective Date
August 04, 2022
Sponsor
Manufacturer
Country
Germany
Address
Am Brand 1, Turkenfeld, 82299