Australia flagARTG 449372

Transcutaneous bilirubinometer

ARTG ID: 449372 · 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
ARTG ID
449372
Start Date
May 22, 2024
Effective Date
May 22, 2024
Sponsor
Manufacturer
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 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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