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Hyperthermia device, insect bite/sting - ARTG 466345

Access comprehensive regulatory information for Hyperthermia device, insect bite/sting in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 466345 and sponsored by Tempo Australia Pty Ltd, manufactured by AOJ HEALTH Technology Co Ltd in China. The device registration started on October 29, 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 IIa
ARTG 466345
Class IIa
Hyperthermia device, insect bite/sting
ARTG ID: 466345
Good Name: Tempo Australia Pty Ltd - Hyperthermia device, insect bite/sting
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Intended Purpose

Localized precise heat can trigger a natural response from the body to reduce itching pain and swelling, works solely through concentrated heat, and treats itch and pain of bites and stings caused by mosquitoes, bees, wasps, bugs, and horseflies.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466345
Start Date
October 29, 2024
Effective Date
October 29, 2024
Manufacturer
Country
China
Address
Room 302 Block A Building A Jingfa Intelligent Manufacturing Park Xiaweiyuan, Gushu Community Xixiang Street, Bao'an District, Shenzhen, 518126