ARTG 378934Multiple physiological parameter spot-check analysis system, home-use
ARTG ID: 378934 · 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
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 378934
- Start Date
- November 25, 2021
- Effective Date
- November 25, 2021
- Country
- China
- Address
- Room 501-2 502 503 North Building Torch Hi-Tech Zone No 56-58 Huoju Road, Xiamen, Fujian, 361000
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.
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 registered under ARTG number 378934 and 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.