ARTG 424292Patient monitor, cardiotocograph
ARTG ID: 424292 · Quintessa Holdings Pty Ltd · Guangzhou Sunray Medical Apparatus Co Ltd · Class IIb · Started October 06, 2023
Good Name: Quintessa Holdings Pty Ltd - Patient monitor, cardiotocograph
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 424292
- Start Date
- October 06, 2023
- Effective Date
- October 06, 2023
- Country
- China
- Address
- 38 Gaoke Road Gaotang Industry District GuangShanEr Road, Guangzhou, 510520
The STAN S41 Maternal and Fetal Monitor is intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing, labor and delivery. It is intended for continuous and auscultatory monitoring of maternal ECG, maternal non-invasive blood pressure (NIBP), maternal oxygen saturation (MSpO2), maternal respiration rate (Resp), uterine activity (UA), fetal movements (FM), and fetal heart rate (FHR) of single fetuses and twins.
Access comprehensive regulatory information for Patient monitor, cardiotocograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 424292 and sponsored by Quintessa Holdings Pty Ltd, manufactured by Guangzhou Sunray Medical Apparatus Co Ltd in China. The device registration started on October 06, 2023.
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.