Australia flagARTG 387400

Fingertip Pulse Oximeter - Pulse oximeter, battery-powered

ARTG ID: 387400 · Frontida Health · Shenzhen IMDK Medical Technology Co Ltd · Class IIa · Started April 22, 2022

Good Name: Frontida Health - Fingertip Pulse Oximeter - Pulse oximeter, battery-powered

Device classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
387400
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
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

About this record

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 registered under ARTG number 387400 and 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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