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Flexible video ureteroscope, single-use - ARTG 465687

Access comprehensive regulatory information for Flexible video ureteroscope, 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 465687 and sponsored by PlainSolution, manufactured by Jiangsu Tuyun Medical Technology Co Ltd in China. The device registration started on October 24, 2024.

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 465687
Class IIa
Flexible video ureteroscope, single-use
ARTG ID: 465687
Good Name: PlainSolution - Flexible video ureteroscope, single-use
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Intended Purpose

It is an endoscope intended for the visual examination and treatment of the ureter. It is inserted through the external urethral orifice and bladder during ureteroscopy. This device is normally used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465687
Start Date
October 24, 2024
Effective Date
October 24, 2024
Sponsor
Manufacturer
Country
China
Address
4F Building 9 Graphene Industrial Park No 8 Lanxiang Rd, West Taihu Lake Science and Technology Industrial Zone, Changzhou, Jiangsu, 213149