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Transcutaneous bilirubinometer - ARTG 464807

Access comprehensive regulatory information for Transcutaneous bilirubinometer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 464807 and sponsored by Koala Medical Pty Ltd, manufactured by Ningbo David Medical Device Co Ltd in China. The device registration started on October 17, 2024.

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 464807
Class IIa
Transcutaneous bilirubinometer
ARTG ID: 464807
Good Name: Koala Medical Pty Ltd - Transcutaneous bilirubinometer
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Intended Purpose

The jaundice detector is used to quickly and non-invasively detect the transcutaneous value of neonatal serum bilirubin. These values can be obtained from the outer epidermis of neonatal skin before, during, and after phototherapy.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464807
Start Date
October 17, 2024
Effective Date
October 17, 2024
Manufacturer
Country
China
Address
No 2 Keyuan Road Shipu Science and Technology Park, Xiangshan, Ningbo, Zhejiang Province, 315731