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Heating unit, pad, water, control unit - ARTG 476207

Access comprehensive regulatory information for Heating unit, pad, water, control unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476207 and sponsored by Fairmont Medical Products Pty Ltd, manufactured by Gentherm Medical LLC in United States of America. The device registration started on January 20, 2025.

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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TGA ARTG Official Data
Class IIb
ARTG 476207
Class IIb
Heating unit, pad, water, control unit
ARTG ID: 476207
Good Name: Fairmont Medical Products Pty Ltd - Heating unit, pad, water, control unit
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Intended Purpose

A device is used maintain, lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer or to maintain a desired patient temperature through conductive heat transfer.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476207
Start Date
January 20, 2025
Effective Date
January 20, 2025
Manufacturer
Country
United States of America
Address
12011 Mosteller Rd Cincinnati, Ohio, 45241