ARTG 474987Cysto-Urethroscope - Cystourethroscope, rigid
ARTG ID: 474987 · Actis Medical Pty Ltd · Hangzhou Hawk Optical Electronic Instruments Co Ltd · Class I · Started January 03, 2025
Good Name: Actis Medical Pty Ltd - Cysto-Urethroscope - Cystourethroscope, rigid
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 474987
- Start Date
- January 03, 2025
- Effective Date
- January 03, 2025
- Country
- China
- Address
- 9 Xinda Road Suoqian Xiaoshan, Hangzhou, Zhejiang, 311201
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.
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.