Australia TGA ARTG record

Analyser, bilirubinometer

Australia TGA ARTG Registered Device · Fusion Healthcare Pty Ltd · Beijing M&B Electronic Instruments Co Ltd · Class IIa · Started January 14, 2013

Good Name: Fusion Healthcare Pty Ltd - Analyser, bilirubinometer

Device classification

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

Registration information

Start Date: January 14, 2013
Effective Date: January 14, 2013

Sponsor

Name: Fusion Healthcare Pty Ltd

Manufacturer

Name: Beijing M&B Electronic Instruments Co Ltd
Country: China
Address: No 27 Yongwang Rd Beijing Bioengineering & Medicine Industry Base, Huangcun Town Daxing District, Beijing, 102629

Intended purpose

MBJ20 Transcutaneous Jaundice Detector is a portable instrument which is mainly used in the clinical examination of neonatal jaundice. The transcutaneous concentration of bilirubin correlative with serum bilirubin concentration can be determined instantly and non-invasively by placing the detector on the neonatal skin. This prevents the neonates from any discomfort typically associated with abstraction of blood samples.

About this record

Access comprehensive regulatory information for Analyser, bilirubinometer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Fusion Healthcare Pty Ltd, manufactured by Beijing M&B Electronic Instruments Co Ltd in China. The device registration started on January 14, 2013.

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.