Australia TGA ARTG record

Probe, thermometer, single use

Australia TGA ARTG Registered Device · Vyaire Medical Pty Ltd · Vyaire Medical Oy · Class IIa · Started January 24, 2019

Good Name: Vyaire Medical Pty Ltd - Probe, thermometer, single use

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 24, 2019
Effective Date: January 24, 2019

Sponsor

Name: Vyaire Medical Pty Ltd

Manufacturer

Name: Vyaire Medical Oy
Country: Finland
Address: Kuortaneenkatu 2, Helsinki, FI-00510

Intended purpose

The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with GE Healthcare monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

About this record

Access comprehensive regulatory information for Probe, thermometer, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Vyaire Medical Pty Ltd, manufactured by Vyaire Medical Oy in Finland. The device registration started on January 24, 2019.

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.