Australia TGA ARTG record

Hypodermic needle, single-use, sterile

Australia TGA ARTG Registered Device · Austramedex (Vic) Pty Ltd · Unisis Corp · Class IIa · Started October 30, 2020

Good Name: Austramedex (Vic) Pty Ltd - Hypodermic needle, single-use, sterile

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 30, 2020
Effective Date: October 30, 2020

Sponsor

Name: Austramedex (Vic) Pty Ltd

Manufacturer

Name: Unisis Corp
Country: Japan
Address: Saitama Plant 2675-1 Nishikata Koshigaya-shi, Saitama, 343-0822

Intended purpose

A sterile, sharp injection needle intended to be used in conjunction with a syringe to prepare and administer fluids/medications/drugs to a patient. This is a single use device.

About this record

Access comprehensive regulatory information for Hypodermic needle, single-use, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Austramedex (Vic) Pty Ltd, manufactured by Unisis Corp in Japan. The device registration started on October 30, 2020.

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.