ARTG 481288Flexible video ureterorenoscope, single-use
ARTG ID: 481288 · Actis Medical Pty Ltd · Shenzhen HugeMed Medical Technical Development Co Ltd · Class IIa · Started February 28, 2025
Good Name: Actis Medical Pty Ltd - Flexible video ureterorenoscope, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 481288
- Start Date
- February 28, 2025
- Effective Date
- February 28, 2025
- Country
- China
- Address
- 401 501 Building 4 Haizhi Technology Park Fortis No 17 Bulan Road, Xialilang Community Nanwan Street Longgang District, Shenzhen, Guangdong, 518112
The device is introduced within the urinary tract for endoscopic examination or treatment. The device can be used to examine the urinary tract and interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. This is to be performed by skilled physicians trained in clinical endoscopic techniques and procedures. Images are transmitted to the user through a Medical Image Processor for clinical image processing. This is a single-use device.
Access comprehensive regulatory information for Flexible video ureterorenoscope, 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 481288 and sponsored by Actis Medical Pty Ltd, manufactured by Shenzhen HugeMed Medical Technical Development Co Ltd in China. The device registration started on February 28, 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.