Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Buddy Sell Pty Ltd · Shenzhen IMDK Medical Technology Co Ltd · Class IIa · Started November 30, 2021

Good Name: Buddy Sell Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: November 30, 2021
Effective Date: November 30, 2021

Sponsor

Name: Buddy Sell Pty Ltd

Manufacturer

Name: Shenzhen IMDK Medical Technology Co Ltd
Country: China
Address: C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106

Intended purpose

Fingertip pulse oximeter is a portable non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

About this record

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 sponsored by Buddy Sell Pty Ltd, manufactured by Shenzhen IMDK Medical Technology Co Ltd in China. The device registration started on November 30, 2021.

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.