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Biopsy kit, soft tissue - ARTG 468509

Access comprehensive regulatory information for Biopsy kit, soft tissue in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 468509 and sponsored by BTC Speciality Health Pty Ltd, manufactured by IZI Medical Products LLC in United States of America. The device registration started on November 13, 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.

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Class IIa
ARTG 468509
Class IIa
Biopsy kit, soft tissue
ARTG ID: 468509
Good Name: BTC Speciality Health Pty Ltd - Biopsy kit, soft tissue
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Intended Purpose

Quick Core Auto biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate, and various soft tissue masses). It is not intended for use in bone biopsy.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
468509
Start Date
November 13, 2024
Effective Date
November 13, 2024
Manufacturer
Country
United States of America
Address
5 Easter Court Suite J, Owings Mills, MD, 21117