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Catheter, nephrostomy - ARTG 305960

Access comprehensive regulatory information for Catheter, nephrostomy in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 305960 and sponsored by Key Medical Pty Ltd, manufactured by Dalian Create Medical Products Co Ltd in China. The device registration started on June 29, 2018.

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 305960
Class IIa
Catheter, nephrostomy
ARTG ID: 305960
Good Name: Key Medical Pty Ltd - Catheter, nephrostomy
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Intended Purpose

Nephrostomy catheter intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large bore (sizes from 14 to 24 Fr are typical) thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. This device is used to perform drainage for relief of supravesical obstructions and also for a variety of procedures of the upper urinary tract, e.g. dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones or ureteral stenting.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
305960
Start Date
June 29, 2018
Effective Date
June 29, 2018
Manufacturer
Country
China
Address
No IIB-31 Dalian Exp Processing Zone, Dalian, Liaoning Province, 116600