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Ureteral stent, polymeric - ARTG 474445

Access comprehensive regulatory information for Ureteral stent, polymeric in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 474445 and sponsored by Coloplast Pty Ltd, manufactured by Coloplast AS in Denmark. The device registration started on December 23, 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 IIb
ARTG 474445
Class IIb
Ureteral stent, polymeric
ARTG ID: 474445
Good Name: Coloplast Pty Ltd - Ureteral stent, polymeric
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Intended Purpose

The NovoFlowTM Reinforced Ureteral Stents are intended for patients 12 years of age (40kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing the ureter. These stents may remain implanted for up to 6 months.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474445
Start Date
December 23, 2024
Effective Date
December 23, 2024
Manufacturer
Country
Denmark
Address
Holtedam 1, Humlebaek, 3050