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Transcutaneous bilirubinometer - ARTG 449372

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 449372 and sponsored by Swirl Technologies Pty Ltd T/A Parker Healthcare, manufactured by Ningbo David Medical Device Co Ltd in China. The device registration started on May 22, 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 449372
Class IIa
Transcutaneous bilirubinometer
ARTG ID: 449372
Good Name: Swirl Technologies Pty Ltd T/A Parker Healthcare - 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
449372
Start Date
May 22, 2024
Effective Date
May 22, 2024
Manufacturer
Country
China
Address
No 2 Keyuan Road Shipu Science and Technology Park, Xiangshan, Ningbo, Zhejiang Province, 315731