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Flexible ureteral sheath/fibreoptic telescope - ARTG 468167

Access comprehensive regulatory information for Flexible ureteral sheath/fibreoptic telescope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 468167 and sponsored by Endotherapeutics Pty Ltd, manufactured by Innovex Medical Co Ltd in China. The device registration started on November 12, 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 468167
Class IIa
Flexible ureteral sheath/fibreoptic telescope
ARTG ID: 468167
Good Name: Endotherapeutics Pty Ltd - Flexible ureteral sheath/fibreoptic telescope
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Intended Purpose

The Ureteral Access Sheath is intended to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
468167
Start Date
November 12, 2024
Effective Date
November 12, 2024
Manufacturer
Country
China
Address
2nd Floor No 17 Building 315 Qingda Road, Pudong, Shanghai, 201201