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Flexible video cystoscope, single-use - ARTG 484245

Access comprehensive regulatory information for Flexible video cystoscope, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 484245 and sponsored by Sungo Australia Pty Ltd, manufactured by Shanghai SeeGen Photoelectric Technology Co Ltd in China. The device registration started on March 26, 2025.

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
ARTG 484245
Class IIa
Flexible video cystoscope, single-use
ARTG ID: 484245
Good Name: Sungo Australia Pty Ltd - Flexible video cystoscope, single-use
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Intended Purpose

This product is intended to be used for observation, diagnosis and treatment of the lower urinary tract. This product is intended to provide visualisation via the Imaging Processor System and can be used with endoscopic accessories.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484245
Start Date
March 26, 2025
Effective Date
March 26, 2025
Manufacturer
Country
China
Address
3rd Floor Building 1 4299 JinDu Road, Minhang District, Shanghai, 201108