Australia TGA ARTG record

Multiple physiological parameter spot-check analysis system, home-use

Australia TGA ARTG Registered Device · Health Teams Pty Ltd · Xiamen Linktop Technology Co Ltd · Class IIa · Started November 25, 2021

Good Name: Health Teams Pty Ltd - Multiple physiological parameter spot-check analysis system, home-use

Device classification

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

Registration information

Start Date: November 25, 2021
Effective Date: November 25, 2021

Sponsor

Name: Health Teams Pty Ltd

Manufacturer

Name: Xiamen Linktop Technology Co Ltd
Country: China
Address: Room 501-2 502 503 North Building Torch Hi-Tech Zone No 56-58 Huoju Road, Xiamen, Fujian, 361000

Intended purpose

The Linktop Health monitor consists of the active device itself powered by a Lithium rechargeable battery, a blood pressure bicep cuff and a smart phone app. The Health Monitor is intended to be used for measuring, displaying and storing of the following parameters: 1)Body temperature - scanning the forehead area 2)Blood pressure using the bicep cuff 3)Pulse rate by placing an index finger 4)Oxygenation - SPO2 5)Blood glucose level - with a test strip This device isn’t intended to allow direct diagnosis and will usually be used in a remote patient monitoring scenario or in a telehealth environment where a doctor or nurse will be present. In the context of the Health Teams it will be used within aged care residences.

About this record

Access comprehensive regulatory information for Multiple physiological parameter spot-check analysis system, home-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Health Teams Pty Ltd, manufactured by Xiamen Linktop Technology Co Ltd in China. The device registration started on November 25, 2021.

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.