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Side-notch biopsy gun, single-use - ARTG 445694

Access comprehensive regulatory information for Side-notch biopsy gun, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 445694 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Hologic Inc in United States of America. The device registration started on April 11, 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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TGA ARTG Official Data
Class IIa
ARTG 445694
Class IIa
Side-notch biopsy gun, single-use
ARTG ID: 445694
Good Name: Hologic (Australia & New Zealand) Pty Ltd - Side-notch biopsy gun, single-use
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Intended Purpose

The biopsy needle primarily consists of a hollow needle with a side aperture and a sharpened inner cannula that is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging. The biopsy needle is single-use and is disposable.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445694
Start Date
April 11, 2024
Effective Date
April 11, 2024
Manufacturer
Country
United States of America
Address
250 Campus Drive, Marlborough, MA, 01752