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Pulse oximeter, battery-powered - ARTG 418076

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 418076 and sponsored by Tempo Australia Pty Ltd, manufactured by Shenzhen Jumper Medical Equipment Co Ltd in China. The device registration started on August 14, 2023.

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 418076
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 418076
Good Name: Tempo Australia Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

this device is used to monitor the physiological signal, included. arterial oxygen saturation sp02 and pulse rate (PR) by clipping the device to the finger. The device measures these physiological signs(sp02 and PR) of clients then the numerical results are displayed on the screen. The device is used for regular monitoring purposes in aged care, retirement villages, and homes. The device is not intended for diagnostic purposes.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
418076
Start Date
August 14, 2023
Effective Date
August 14, 2023
Manufacturer
Country
China
Address
D Building No 71 Xintian Road Fuyong Street Baoan, Shenzhen, Guangdong, 518103