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Fingertip Pulse Oximeter - Pulse oximeter, battery-powered

Access comprehensive regulatory information for Fingertip Pulse Oximeter - 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 Frontida Health, manufactured by Shenzhen IMDK Medical Technology Co Ltd in China. The device registration started on April 22, 2022.

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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TGA ARTG Official Data
Class IIa
Class IIa
Fingertip Pulse Oximeter - Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: Frontida Health - Fingertip Pulse Oximeter - Pulse oximeter, battery-powered
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Intended Purpose

An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and also measure/display pulse rate. It is applied to the fingertip and it is intended to be operated by laypersons and healthcare providers

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 22, 2022
Effective Date
April 22, 2022
Sponsor
Manufacturer
Country
China
Address
C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106