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Biopsy kit, ultrasonic aspiration - ARTG 462200

Access comprehensive regulatory information for Biopsy kit, ultrasonic aspiration in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462200 and sponsored by William A Cook Australia Pty Ltd, manufactured by Cook Ireland Ltd in Ireland. The device registration started on September 12, 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 462200
Class IIa
Biopsy kit, ultrasonic aspiration
ARTG ID: 462200
Good Name: William A Cook Australia Pty Ltd - Biopsy kit, ultrasonic aspiration
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Intended Purpose

This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462200
Start Date
September 12, 2024
Effective Date
September 12, 2024
Manufacturer
Country
Ireland
Address
O'Halloran Road National Technology Park, Limerick