Australia TGA ARTG record

Infrared Thermometers FC-IR100,FC-IR101,FC-IR200,FC-IR2-2.FC-IR300,FC-IR400 FC-IR202,FC-IR2000,FC-IR205,FC-IR105,FC-IR206,FC-IR207,FC-IR1030,FC-IR3010 - Thermometer, infrared, skin

Australia TGA ARTG Registered Device · Frontida Health · Shenzhen Finicare Co Ltd · Class IIa · Started May 16, 2022

Good Name: Frontida Health - Infrared Thermometers FC-IR100,FC-IR101,FC-IR200,FC-IR2-2.FC-IR300,FC-IR400 FC-IR202,FC-IR2000,FC-IR205,FC-IR105,FC-IR206,FC-IR207,FC-IR1030,FC-IR3010 - Thermometer, infrared, skin

Device classification

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

Registration information

Start Date: May 16, 2022
Effective Date: May 16, 2022

Sponsor

Name: Frontida Health

Manufacturer

Name: Shenzhen Finicare Co Ltd
Country: China
Address: 201 No 50 the 3rd Industrial Park, Houting Community Shajing Street, Bao'an District, Shenzhen, 518104

Intended purpose

A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device

About this record

Access comprehensive regulatory information for Infrared Thermometers FC-IR100,FC-IR101,FC-IR200,FC-IR2-2.FC-IR300,FC-IR400 FC-IR202,FC-IR2000,FC-IR205,FC-IR105,FC-IR206,FC-IR207,FC-IR1030,FC-IR3010 - Thermometer, infrared, skin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Frontida Health, manufactured by Shenzhen Finicare Co Ltd in China. The device registration started on May 16, 2022.

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.