Australia flagARTG 388768

neoBLUE compact LED Phototherapy System - Light therapy unit, photo

ARTG ID: 388768 · 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 compact LED Phototherapy System - Light therapy unit, photo

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
388768
Start Date
May 20, 2022
Effective Date
May 20, 2022
Sponsor
Manufacturer
Country
Canada
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1
Intended purpose

intended for the treatment of neonatal hyperbilirubinemia. Portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (LEDs)

About this record

Access comprehensive regulatory information for neoBLUE compact LED Phototherapy System - Light therapy unit, photo in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 388768 and 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.

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