ARTG 413949Pulse oximeter, battery-powered
ARTG ID: 413949 · Ozismart Pty Ltd · Shenzhen IMDK Medical Technology Co Ltd · Class IIa · Started July 21, 2023
Good Name: Ozismart Pty Ltd - Pulse oximeter, battery-powered
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 413949
- Start Date
- July 21, 2023
- Effective Date
- July 21, 2023
- Name
- Ozismart Pty Ltd
- Country
- China
- Address
- C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106
This device is intended for use for measuring 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 measures/displays pulse rate. It is applied to the fingertip and it is intended to be operated by layperson and healthcare providers.
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 413949 and sponsored by Ozismart Pty Ltd, manufactured by Shenzhen IMDK Medical Technology Co Ltd in China. The device registration started on July 21, 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.