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Transcutaneous blood gas monitor - ARTG 428190

Access comprehensive regulatory information for Transcutaneous blood gas monitor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 428190 and sponsored by Sentec Monitoring Pty Ltd, manufactured by SenTec AG in Switzerland. The device registration started on November 20, 2023.

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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Class IIb
ARTG 428190
Class IIb
Transcutaneous blood gas monitor
ARTG ID: 428190
Good Name: Sentec Monitoring Pty Ltd - Transcutaneous blood gas monitor
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Intended Purpose

The tCOM+ Patient Monitor is a portable stand-alone patient monitor intended for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2), and pulse rate (PR).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
428190
Start Date
November 20, 2023
Effective Date
November 20, 2023
Manufacturer
Country
Switzerland
Address
Ringstr 39, Therwil, Switzerland, 4106