Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Silverline Medical Pty Ltd · Shenzhen IMDK Medical Technology Co Ltd · Class IIa · Started October 11, 2021

Good Name: Silverline Medical Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: October 11, 2021
Effective Date: October 11, 2021

Sponsor

Name: Silverline Medical Pty Ltd

Manufacturer

Name: Shenzhen IMDK Medical Technology Co Ltd
Country: China
Address: C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106

Intended purpose

A device for transcutaneous measurement of oxygen saturation in the blood using light detection. Pulse rate can also be determined. The device is intended for consumers for consumers to be able to monitor their own blood oxygen levels.

About this record

Access comprehensive regulatory information for Pulse oximeter, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Silverline Medical Pty Ltd, manufactured by Shenzhen IMDK Medical Technology Co Ltd in China. The device registration started on October 11, 2021.

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.