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Pulse oximeter, battery-powered - ARTG 376081

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 registered under ARTG number 376081 and 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.

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Class IIa
ARTG 376081
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 376081
Good Name: Silverline Medical Pty Ltd - Pulse oximeter, battery-powered
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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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
376081
Start Date
October 11, 2021
Effective Date
October 11, 2021
Manufacturer
Country
China
Address
C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106