ARTG 475927

Pulse oximeter, battery-powered

ARTG ID: 475927 · 2San Pty Ltd · Shanghai Berry Electronic Tech Co Ltd · Class IIa · Started January 16, 2025

Good Name: 2San Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

ARTG ID: 475927
Start Date: January 16, 2025
Effective Date: January 16, 2025

Sponsor

Name: 2San Pty Ltd

Manufacturer

Name: Shanghai Berry Electronic Tech Co Ltd
Country: China
Address: Unit 104 1st Floor 7th Building No 1188 Lianhang Road, Minhang District, Shanghai, 201112

Intended purpose

The pulse oximeter is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults. This medical device can be reused. Not for continuously monitoring.

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 registered under ARTG number 475927 and sponsored by 2San Pty Ltd, manufactured by Shanghai Berry Electronic Tech Co Ltd in China. The device registration started on January 16, 2025.

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.