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Electronic oesophageal stethoscope, single-use

Access comprehensive regulatory information for Electronic oesophageal stethoscope, 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 December 19, 2017.

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 IIa
Class IIa
Electronic oesophageal stethoscope, single-use
Australia TGA ARTG Registered Device
Good Name: Vyaire Medical Pty Ltd - Electronic oesophageal stethoscope, single-use
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Intended Purpose

An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 19, 2017
Effective Date
December 19, 2017
Manufacturer
Country
Finland
Address
Kuortaneenkatu 2, Helsinki, FI-00510