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Probe, pulse oximeter, reusable

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 Genesis Biotech Pty Ltd, manufactured by Shenzhen Creative Industry Co Ltd in China. The device registration started on July 05, 2022.

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Probe, pulse oximeter, reusable
Australia TGA ARTG Registered Device
Good Name: Genesis Biotech Pty Ltd - Probe, pulse oximeter, reusable
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Intended Purpose

SpO2 sensor probe intended to be used with a compatible patient monitor or a pulse oximeter device for non-invasively monitoring of functional arterial oxygen saturation (SpO2) and pulse rate (PR) for adult and pediatric patients. Reusable for the same patient only.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 05, 2022
Effective Date
July 05, 2022
Manufacturer
Country
China
Address
Floor 5 BLD 9 BaiWangxin High-Tech Industrial Park Songbai Road Xili Street, Nanshan District, Shenzhen, 518110