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Cysto-Urethroscope - Cystourethroscope, rigid - ARTG 474987

Access comprehensive regulatory information for Cysto-Urethroscope - Cystourethroscope, rigid in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 474987 and sponsored by Actis Medical Pty Ltd, manufactured by Hangzhou Hawk Optical Electronic Instruments Co Ltd in China. The device registration started on January 03, 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 I
ARTG 474987
Class I
Cysto-Urethroscope - Cystourethroscope, rigid
ARTG ID: 474987
Good Name: Actis Medical Pty Ltd - Cysto-Urethroscope - Cystourethroscope, rigid
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Intended Purpose

The Cysto-Urethroscope is a reusable device system intended to be used to assist with the visual examination of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user via a relayed lens optics or a fiberoptic bundle. The device system is comprised of the cysto-urethroscope, a sheath, and obturator.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
474987
Start Date
January 03, 2025
Effective Date
January 03, 2025
Manufacturer
Country
China
Address
9 Xinda Road Suoqian Xiaoshan, Hangzhou, Zhejiang, 311201