Australia TGA ARTG record

Heating unit, pad, water, control unit

Australia TGA ARTG Registered Device · PX 210 Pty Ltd T/a New Medical · Belmont Medical Technologies · Class IIb · Started October 20, 2020

Good Name: PX 210 Pty Ltd T/a New Medical - Heating unit, pad, water, control unit

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: October 20, 2020
Effective Date: October 20, 2020

Sponsor

Name: PX 210 Pty Ltd T/a New Medical

Manufacturer

Name: Belmont Medical Technologies
Country: United States of America
Address: 780 Boston Road, Billerica, Massachusetts, 01821

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.

About this record

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 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.