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Probe, pulse oximeter, reusable - ARTG 457347

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 457347 and sponsored by Mediris Pty Ltd, manufactured by Shenzhen Med-link Electronics Tech Co Ltd in China. The device registration started on July 29, 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.

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TGA ARTG Official Data
Class IIb
ARTG 457347
Class IIb
Probe, pulse oximeter, reusable
ARTG ID: 457347
Good Name: Mediris Pty Ltd - Probe, pulse oximeter, reusable
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Intended Purpose

A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as arterial oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection.The device is reusable.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
457347
Start Date
July 29, 2024
Effective Date
July 29, 2024
Sponsor
Manufacturer
Country
China
Address
2nd 4th and 5th Floor Building Two Hualian Industrial Zone, Xinshi Community Dalang Street, Longhua District Shenzhen, 518109