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CT3000 Pro Console - Urodynamic measurement system

Access comprehensive regulatory information for CT3000 Pro Console - Urodynamic measurement system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Surgical Solutions Pty Ltd, manufactured by SRS Medical Systems Inc dba Fasstech in United States of America. The device registration started on September 18, 2023.

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
Class IIa
CT3000 Pro Console - Urodynamic measurement system
Australia TGA ARTG Registered Device
Good Name: Surgical Solutions Pty Ltd - CT3000 Pro Console - Urodynamic measurement system
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Intended Purpose

For diagnosis/study of the bladder. Measurement of urinary flow rate, urethral pressure, bladder capacity and response, and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). This is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g. neurogenic bladder diseases, stress incontinence, urinary path obstruction or deficient sphincters

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 18, 2023
Effective Date
September 18, 2023
Manufacturer
Country
United States of America
Address
76 Treble Cove Road Building #3, North Billerica, Massachusetts, 01862