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Wearable neonatal heart rate meter - ARTG 311701

Access comprehensive regulatory information for Wearable neonatal heart rate meter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 311701 and sponsored by Laerdal Pty Ltd, manufactured by Laerdal Medical AS in Norway. The device registration started on November 20, 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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Class IIa
ARTG 311701
Class IIa
Wearable neonatal heart rate meter
ARTG ID: 311701
Good Name: Laerdal Pty Ltd - Wearable neonatal heart rate meter
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Intended Purpose

NeoBeat and NeoBeat Mini are intended to measure the heart rate of a newborn within the first few hours after delivery.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
311701
Start Date
November 20, 2018
Effective Date
November 20, 2018
Sponsor
Manufacturer
Country
Norway
Address
PO Box 377 Tanke Svilandsgate 30, Stavanger, 4002