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SLE uSpO2 kit - Patient monitor module, oximeter, pulse - ARTG 309164

Access comprehensive regulatory information for SLE uSpO2 kit - Patient monitor module, oximeter, pulse in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 309164 and sponsored by Device Technologies Australia Pty Ltd, manufactured by SLE Ltd in United Kingdom. The device registration started on September 11, 2018.

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 309164
Class IIb
SLE uSpO2 kit - Patient monitor module, oximeter, pulse
ARTG ID: 309164
Good Name: Device Technologies Australia Pty Ltd - SLE uSpO2 kit - Patient monitor module, oximeter, pulse
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Intended Purpose

A set of devices intended to be connected to a patient monitor and allow continuous non-invasive monitoring of pulse rate and blood oxygen saturation in neonatal, infant and paediatric patients.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
309164
Start Date
September 11, 2018
Effective Date
September 11, 2018
Manufacturer
Country
United Kingdom
Address
Unit 7/8 Commerce Park Commerce Way, Croydon, CR0 4YL