ARTG 454485Single-patient physiologic monitoring system
ARTG ID: 454485 · Draeger Australia Pty Ltd · Shanghai Drager Medical Instrument Co Ltd · Class IIb · Started July 05, 2024
Good Name: Draeger Australia Pty Ltd - Single-patient physiologic monitoring system
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 454485
- Start Date
- July 05, 2024
- Effective Date
- July 05, 2024
- Country
- China
- Address
- 3# No 229 Hupo Road Shanghai International Medical Zone, Pudong New Area, Shanghai, 201321
The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic Gas(AG), bispectral indexTM (BIS), neuromuscular transmission (NMT). The monitors are not intended for MRI environments.
Access comprehensive regulatory information for Single-patient physiologic monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 454485 and sponsored by Draeger Australia Pty Ltd, manufactured by Shanghai Drager Medical Instrument Co Ltd in China. The device registration started on July 05, 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.