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Insulin syringe, retractable-needle - ARTG 458129

Access comprehensive regulatory information for Insulin syringe, retractable-needle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 458129 and sponsored by Multigate Medical Devices Pty Ltd, manufactured by Promisemed Hangzhou Meditech Co Ltd in China. The device registration started on August 01, 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 458129
Class IIa
Insulin syringe, retractable-needle
ARTG ID: 458129
Good Name: Multigate Medical Devices Pty Ltd - Insulin syringe, retractable-needle
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DJ Fang

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Intended Purpose

A sterile device intended to be used to administer an injection of insulin to a patient subcutaneously. It includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
458129
Start Date
August 01, 2024
Effective Date
August 01, 2024
Manufacturer
Country
China
Address
No 1388 Cangxing Street Cangqian Community Yuhang District, Hangzhou City, Zhejiang, 311121