Australia TGA ARTG record

Probe, pulse oximeter, reusable

Australia TGA ARTG Registered Device · Meditech Systems Asia Pacific Pty Ltd · Shenzhen Medke Technology Co Ltd · Class IIb · Started May 28, 2024

Good Name: Meditech Systems Asia Pacific Pty Ltd - Probe, pulse oximeter, reusable

Device classification

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

Registration information

Start Date: May 28, 2024
Effective Date: May 28, 2024

Sponsor

Name: Meditech Systems Asia Pacific Pty Ltd

Manufacturer

Name: Shenzhen Medke Technology Co Ltd
Country: China
Address: 401 503 Bldg A1 Anle Ind Zone No 172 Hangcheng Rd Sanwei Community, Hangcheng Street, Baoan District, Shenzhen, 518126

Intended purpose

SpO2 sensors clip onto the body (typically a finger, an earlobe, or an infant's foot) to aid in monitoring saturated oxygen in the bloodstream. This sensor transfers information to a parent device.This SpO2 sensor is a reusable device.

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 Meditech Systems Asia Pacific Pty Ltd, manufactured by Shenzhen Medke Technology Co Ltd in China. The device registration started on May 28, 2024.

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.