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General-purpose infusion pump, battery-powered - ARTG 421412

Access comprehensive regulatory information for General-purpose infusion pump, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 421412 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Ace Medical Co Ltd in South Korea. The device registration started on September 07, 2023.

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 IIb
ARTG 421412
Class IIb
General-purpose infusion pump, battery-powered
ARTG ID: 421412
Good Name: Teleflex Medical Australia Pty Ltd - General-purpose infusion pump, battery-powered
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Intended Purpose

The AutoMed 3200 which is DC 6V powered infusion pump is intended to be used for pain control to connect with AutoMed infusion set. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/ body cavity) site. AutoMed 3200 is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative and postoperative surgery.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421412
Start Date
September 07, 2023
Effective Date
September 07, 2023
Manufacturer
Country
South Korea
Address
33 Naeyoo-Road 124 Deogyang-Gu Goyang-Si, Gyeonggi-Do