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Urethral catheter, drainage, indwelling, temperature-monitoring - ARTG 460685

Access comprehensive regulatory information for Urethral catheter, drainage, indwelling, temperature-monitoring in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 460685 and sponsored by Stryker Australia Pty Ltd, manufactured by DeRoyal Industries Inc in United States of America. The device registration started on August 26, 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 460685
Class IIb
Urethral catheter, drainage, indwelling, temperature-monitoring
ARTG ID: 460685
Good Name: Stryker Australia Pty Ltd - Urethral catheter, drainage, indwelling, temperature-monitoring
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Intended Purpose

Foley catheter with temperature sensor to be used for drainage of the urinary bladder and simultaneous monitoring of core body temperature.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460685
Start Date
August 26, 2024
Effective Date
August 26, 2024
Manufacturer
Country
United States of America
Address
200 DeBusk Lane, Powell, TN, 37849