Australia TGA ARTG record

Catheter, nephrostomy

Australia TGA ARTG Registered Device · Key Medical Pty Ltd · Dalian Create Medical Products Co Ltd · Class IIa · Started June 29, 2018

Good Name: Key Medical Pty Ltd - Catheter, nephrostomy

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 29, 2018
Effective Date: June 29, 2018

Sponsor

Name: Key Medical Pty Ltd

Manufacturer

Name: Dalian Create Medical Products Co Ltd
Country: China
Address: No IIB-31 Dalian Exp Processing Zone, Dalian, Liaoning Province, 116600

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.

About this record

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 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.