Australia TGA ARTG record

Transcutaneous bilirubinometer

Australia TGA ARTG Registered Device · Swirl Technologies Pty Ltd T/A Parker Healthcare · Ningbo David Medical Device Co Ltd · Class IIa · Started May 22, 2024

Good Name: Swirl Technologies Pty Ltd T/A Parker Healthcare - Transcutaneous bilirubinometer

Device classification

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

Registration information

Start Date: May 22, 2024
Effective Date: May 22, 2024

Sponsor

Name: Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Name: Ningbo David Medical Device Co Ltd
Country: China
Address: No 2 Keyuan Road Shipu Science and Technology Park, Xiangshan, Ningbo, Zhejiang Province, 315731

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.

About this record

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 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.