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Endotherapy needle, single use - ARTG 461028

Access comprehensive regulatory information for Endotherapy needle, 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 461028 and sponsored by C R Kennedy & Co Pty Ltd, manufactured by Yangzhou Fartley Medical Instrument Technology Co Ltd in China. The device registration started on August 28, 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 461028
Class IIa
Endotherapy needle, single use
ARTG ID: 461028
Good Name: C R Kennedy & Co Pty Ltd - Endotherapy needle, single use
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DJ Fang

DJ Fang

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Intended Purpose

Endoscopic needle intended be used with a compatible endoscope for various functions (e.g. injection, aspiration, puncture) during endoscopy. It is in the form of a flexible tube with a needle at the distal end and syringe connector at the proximal end. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
461028
Start Date
August 28, 2024
Effective Date
August 28, 2024
Manufacturer
Country
China
Address
Beizhou Road, Lidian Town Guangling District Yangzhou, Jiangsu, 225106