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Pulse oximeter, battery-powered - ARTG 393455

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 393455 and sponsored by J A Davey Pty Ltd, manufactured by Shenzhen Jumper Medical Equipment Co Ltd in China. The device registration started on August 04, 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
ARTG 393455
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 393455
Good Name: J A Davey Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

Intended to be used for non-invasive spot-check measurements of functional oxygen saturation of arterial haemoglobin (Sp02) using a Bluetooth connected App. The Pulse Oximeter can be used to measure human oxygen saturation and pulse rate through the finger.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
393455
Start Date
August 04, 2022
Effective Date
August 04, 2022
Manufacturer
Country
China
Address
D Building No 71 Xintian Road Fuyong Street Baoan, Shenzhen, Guangdong, 518103