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Male urinary outflow analysis system cuff - ARTG 427150

Access comprehensive regulatory information for Male urinary outflow analysis system cuff in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is registered under ARTG number 427150 and sponsored by Surgical Solutions Pty Ltd, manufactured by SRS Medical Systems Inc dba Fasstech in United States of America. The device registration started on October 31, 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 Im
ARTG 427150
Class Im
Male urinary outflow analysis system cuff
ARTG ID: 427150
Good Name: Surgical Solutions Pty Ltd - Male urinary outflow analysis system cuff
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Intended Purpose

The Urocuff-DC is used with an isovolumetric cystometrography in conjunction with ultrasound of the urinary tract provides measurement of urine flow rate and urethral pressure profile including imaging associated with cystometrography.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427150
Start Date
October 31, 2023
Effective Date
October 31, 2023
Manufacturer
Country
United States of America
Address
76 Treble Cove Road Building #3, North Billerica, Massachusetts, 01862