Australia TGA ARTG record

neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit

Australia TGA ARTG Registered Device · Paragon Healthcare Pty Ltd · Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) · Class IIa · Started May 20, 2022

Good Name: Paragon Healthcare Pty Ltd - neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 20, 2022
Effective Date: May 20, 2022

Sponsor

Name: Paragon Healthcare Pty Ltd

Manufacturer

Name: Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek)
Country: Canada
Address: 2568 Bristol Circle, Oakville, Ontario, L6H 5S1

Intended purpose

Intended for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. Provides intensive phototherapy underneath the patient.

About this record

Access comprehensive regulatory information for neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Paragon Healthcare Pty Ltd, manufactured by Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) in Canada. The device registration started on May 20, 2022.

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.