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Stereotactic biopsy system, diagnostic x-ray, mammography - ARTG 445756

Access comprehensive regulatory information for Stereotactic biopsy system, diagnostic x-ray, mammography in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 445756 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Hologic Inc in United States of America. The device registration started on April 15, 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 445756
Class IIa
Stereotactic biopsy system, diagnostic x-ray, mammography
ARTG ID: 445756
Good Name: Hologic (Australia & New Zealand) Pty Ltd - Stereotactic biopsy system, diagnostic x-ray, mammography
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Intended Purpose

The Breast Biopsy System is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445756
Start Date
April 15, 2024
Effective Date
April 15, 2024
Manufacturer
Country
United States of America
Address
250 Campus Drive, Marlborough, MA, 01752