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Heating unit, pad, water, control unit - ARTG 346270

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 346270 and sponsored by PX 210 Pty Ltd T/a New Medical, manufactured by Belmont Medical Technologies in United States of America. The device registration started on October 20, 2020.

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 346270
Class IIb
Heating unit, pad, water, control unit
ARTG ID: 346270
Good Name: PX 210 Pty Ltd T/a New Medical - Heating unit, pad, water, control unit
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Intended Purpose

Cooling and heating device used to thermoregulate a patient's temperature. Used where a patient's core temperature needs to either be maintained at normothermia levels or be lowered to induce therapeutic hypothermia such as post cardiac arrest, neonatal hypoxia, traumatic brain injury. The device achieves this through working in an automated feedback way by circulating water through wraps or pads placed on the outside of the patient's skin surface. The device circulates water either in a heated or chilled form to control a patient's temperature through means of conduction.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
346270
Start Date
October 20, 2020
Effective Date
October 20, 2020
Manufacturer
Country
United States of America
Address
780 Boston Road, Billerica, Massachusetts, 01821