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Elastomeric infusion pump system

Access comprehensive regulatory information for Elastomeric infusion pump system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Ace Medical Co Ltd in South Korea. The device registration started on April 24, 2017.

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 IIb
Class IIb
Elastomeric infusion pump system
Australia TGA ARTG Registered Device
Good Name: Teleflex Medical Australia Pty Ltd - Elastomeric infusion pump system
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Intended Purpose

The elastomeric infusion pump provides continuous and/or intermittent percutaneous infusion of medication for general infusion use, including antibiotic, chemotherapy and pain management therapies. Routes of administration include, intravenous, subcutaneous, intramuscular, and regional. It is also intended for continuous and/or intermittent delivery of medication (such as local anaesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, epidural, or percutaneous.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 24, 2017
Effective Date
April 24, 2017
Manufacturer
Country
South Korea
Address
33 Naeyoo-Road 124 Deogyang-Gu Goyang-Si, Gyeonggi-Do