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Irrigation kit, bladder

Access comprehensive regulatory information for Irrigation kit, bladder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by ICU Medical Australia Pty Ltd, manufactured by ICU Medical Australia Pty Ltd in Australia. The device registration started on October 01, 2021.

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 Is
Class Is
Irrigation kit, bladder
Australia TGA ARTG Registered Device
Good Name: ICU Medical Australia Pty Ltd - Irrigation kit, bladder
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Intended Purpose

A collection of sterile devices designed for the infusion of fluids used to flush and evacuate the bladder of urine and other particulate matter. It may include tubing, connectors, a roller clamp and other items used to flush the bladder. It may be used in such procedures as a cystoscopy or a transurethral resection (TUR) as a means of continuous bladder irrigation. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 01, 2021
Effective Date
October 01, 2021
Manufacturer
Country
Australia
Address
Unit U 10-16 South Street, Rydalmere, NSW, 2116