ARTG 466705

Transport electric ventilator

ARTG ID: 466705 · Mindray Medical Australia Pty Ltd · Shenzhen Mindray Bio Medical Electronics Co Ltd · Class IIb · Started October 31, 2024

Good Name: Mindray Medical Australia Pty Ltd - Transport electric ventilator

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

ARTG ID: 466705
Start Date: October 31, 2024
Effective Date: October 31, 2024

Sponsor

Name: Mindray Medical Australia Pty Ltd

Manufacturer

Name: Shenzhen Mindray Bio Medical Electronics Co Ltd
Country: China
Address: Mindray Building Keji 12th Road South Hi-Tech Industrial Park, Nanshan District, Shenzhen Guangdong, 518057

Intended purpose

The ventilator is intended for providing ventilation assistance and breathing support for patients. The ventilator must only be operated and used by authorized medical personnel well trained in the use of this product. The ventilator can be used in adult, pediatric and infant patients. For prolonged periods of ventilation and respiratory support for patients with apnea or respiratory failure, patients are fully dependent on or partly dependent on such equipment. This product is intended to be used in intensive care situations within a professional healthcare facility, or during transport within a professional healthcare facility and emergency medical services environment such as in ambulances or aircraft, etc.

About this record

Access comprehensive regulatory information for Transport electric ventilator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 466705 and sponsored by Mindray Medical Australia Pty Ltd, manufactured by Shenzhen Mindray Bio Medical Electronics Co Ltd in China. The device registration started on October 31, 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.