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Flexible video ureterorenoscope, single-use - ARTG 481288

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.

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Class IIa
ARTG 481288
Class IIa
Flexible video ureterorenoscope, single-use
ARTG ID: 481288
Good Name: Actis Medical Pty Ltd - Flexible video ureterorenoscope, single-use
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481288
Start Date
February 28, 2025
Effective Date
February 28, 2025
Manufacturer
Country
China
Address
401 501 Building 4 Haizhi Technology Park Fortis No 17 Bulan Road, Xialilang Community Nanwan Street Longgang District, Shenzhen, Guangdong, 518112