Australia TGA ARTG record

Probe, pulse oximeter, reusable

Australia TGA ARTG Registered Device · Mediris Pty Ltd · Shenzhen Best Electronics Co Ltd · Class IIb · Started April 13, 2023

Good Name: Mediris Pty Ltd - Probe, pulse oximeter, reusable

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 13, 2023
Effective Date: April 13, 2023

Sponsor

Name: Mediris Pty Ltd

Manufacturer

Name: Shenzhen Best Electronics Co Ltd
Country: China
Address: Room 605 Building 59 Second Industrial Zone Tianliao Community Yutang Street, Guangming District, Shenzhen

Intended purpose

A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as arterial oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection.The device is reusable.

About this record

Access comprehensive regulatory information for Probe, pulse oximeter, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Mediris Pty Ltd, manufactured by Shenzhen Best Electronics Co Ltd in China. The device registration started on April 13, 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.