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Compress, hot/cold pack, reusable - ARTG 460909

Access comprehensive regulatory information for Compress, hot/cold pack, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 460909 and sponsored by Homedics Australia Pty Ltd, manufactured by Koolcare Technology Co Ltd in China. The device registration started on August 27, 2024.

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 I
ARTG 460909
Class I
Compress, hot/cold pack, reusable
ARTG ID: 460909
Good Name: Homedics Australia Pty Ltd - Compress, hot/cold pack, reusable
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Intended Purpose

A re-usable non-sterile device that is intended to be applied with pressure to a body surface to provide cold or heat therapy to that surface and/or underlying tissue. This device consists of a breathable fabric envelope containing a hydrogel gel capable of forming to the contour of the body. It can be heated or cooled to relieve aches and pains associated with sprains, strains, stiff joints, sore muscles, arthritic pain, headaches and eye-strain.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460909
Start Date
August 27, 2024
Effective Date
August 27, 2024
Manufacturer
Country
China
Address
No 6-10 A5 Shandong International Tech Park South Waihuan Road Linyi, Shandong, 276017