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Probe, pulse oximeter, reusable - ARTG 395964

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 registered under ARTG number 395964 and sponsored by Tenacore Pty Ltd, manufactured by Shenzhen Med-link Electronics Tech Co Ltd in China. The device registration started on September 14, 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
ARTG 395964
Class IIb
Probe, pulse oximeter, reusable
ARTG ID: 395964
Good Name: Tenacore Pty Ltd- Probe, pulse oximeter, reusable
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Intended Purpose

A reusable device applied to a body site, e.g. ear, finger, bridge of nose or foot of paediatric or adult patients, in order to transmit light through the skin to be absorbed by the deoxyhaemoglobin and oxyhaemoglobin, in the arterial tissue blood. Signals are received by the parent device, which displays the results.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
395964
Start Date
September 14, 2022
Effective Date
September 14, 2022
Sponsor
Manufacturer
Country
China
Address
4th and 5th Floor Building Two Hualian Industrial Zone Xinshi Community, Dalang Street, Longhua District, Shenzhen, 518109