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neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit - ARTG 388767

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 registered under ARTG number 388767 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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Class IIa
ARTG 388767
Class IIa
neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit
ARTG ID: 388767
Good Name: Paragon Healthcare Pty Ltd - neoBLUE LED Phototherapy system - Blanket/pad infant phototherapy unit
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388767
Start Date
May 20, 2022
Effective Date
May 20, 2022
Manufacturer
Country
Canada
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1