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Insulin syringe, retractable-needle - ARTG 401142

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 401142 and sponsored by Pacific Health Care Pty Ltd, manufactured by Shantou Wealy Medical Instrument Co Ltd in China. The device registration started on December 15, 2022.

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 401142
Class IIa
Insulin syringe, retractable-needle
ARTG ID: 401142
Good Name: Pacific Health Care Pty Ltd - Insulin syringe, retractable-needle
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Intended Purpose

A sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer an injection of insulin to a patient subcutaneously. It is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle is fully retracted into the plunger, 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
401142
Start Date
December 15, 2022
Effective Date
December 15, 2022
Manufacturer
Country
China
Address
North Jinhuan Road, near of Qishan Mid-school, Shantou, Guangdong, 515064