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Vaccine reuse-prevention syringe/needle - ARTG 389726

Access comprehensive regulatory information for Vaccine reuse-prevention syringe/needle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 389726 and sponsored by Icon International Pty Ltd t/a Icon Medipharm, manufactured by Changzhou Chuangjia Medical Appliance Co Ltd in China. The device registration started on June 07, 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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Class IIa
ARTG 389726
Class IIa
Vaccine reuse-prevention syringe/needle
ARTG ID: 389726
Good Name: Icon International Pty Ltd t/a Icon Medipharm - Vaccine reuse-prevention syringe/needle
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Intended Purpose

A single use sterile device consisting of a transparent barrel/cylinder with plunger which has a built-in safety mechanism preventing reuse [reuse prevention (RUP)], and includes a fixed needle at the distal end, intended to be used for the reconstitution/administration of vaccines and infection prevention. The RUP mechanism may automatically block the plunger once depressed so it cannot be depressed again (e.g., with serrations, hook, or claw on plunger, or rings on barrel) or it may crack the syringe when the plunger is fully depressed to prevent further use.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
389726
Start Date
June 07, 2022
Effective Date
June 07, 2022
Manufacturer
Country
China
Address
Sanhekou Development Zone, Zhenglu Town, Changzhou, 213115