Australia TGA ARTG recordFlexible video choledochoscope, single-use
Australia TGA ARTG Registered Device · Sungo Australia Pty Ltd · Shanghai SeeGen Photoelectric Technology Co Ltd · Class IIa · Started September 21, 2023
Good Name: Sungo Australia Pty Ltd - Flexible video choledochoscope, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- September 21, 2023
- Effective Date
- September 21, 2023
- Country
- China
- Address
- 3rd Floor Building 1 4299 JinDu Road, Minhang District, Shanghai, 201108
The device is an endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract/ducts and removal of gallstones that can only occur with additional accessories.It is used in conjunction with surgical endoscope or laparoscopic instruments (duodenoscopy, trocar, T-tube, etc.), through the established surgical instrument channel, into the bile duct for observation and diagnosis.
Access comprehensive regulatory information for Flexible video choledochoscope, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sungo Australia Pty Ltd, manufactured by Shanghai SeeGen Photoelectric Technology Co Ltd in China. The device registration started on September 21, 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.