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Flexible video choledochoscope, single-use

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Flexible video choledochoscope, single-use
Australia TGA ARTG Registered Device
Good Name: Sungo Australia Pty Ltd - Flexible video choledochoscope, single-use
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 21, 2023
Effective Date
September 21, 2023
Manufacturer
Country
China
Address
3rd Floor Building 1 4299 JinDu Road, Minhang District, Shanghai, 201108