Skip to content

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)

by Radiant Innovation Inc. Taiwan EUDAMED510(k)

510(k) K240648 Product code FLL

Overview

The Non-contact Forehead Thermometer is a medical device designed for quick and concise temperature measurements of humans or objects. It features a large display with green, yellow, and red indicators to show fever status within one second at an 8cm distance.

This device is intended for mass temperature screening in workplaces, public events, and social gatherings without contact to prevent contamination. It is supplied in various models (TH48FE, TH09F, THD2FE) and has been tested to IEC 60601-1 and IEC 60601-1-2 standards for safety and electromagnetic compatibility.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240648 Date5 Jun 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
FLL
FDA applicant
Radiant Innovation, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

From the manufacturer

Radiant TH48FE Series Non-contact Forehead Thermometer is designed for quick and concise temperature measurements of human or objects. Feature a large display green/yellow/red to indicate fever in just one second within 8cm. It's ideal for mass temperature screening without contact or fear of contamination for workplaces, public events and social gatherings.

Source: radiantek.com.tw

Non-contact forehead thermometers take a rapid and convenient reading within one second for hygiene and comfort to avoid cross-infection during the epidemic effectively.

Source: radiantek.com.tw

Other devices from Radiant Innovation Inc.

See all devices from Radiant Innovation Inc. →

Questions

  • What is the purpose of the Non-contact Forehead Thermometer?

    The device is designed for quick temperature measurements of humans or objects, specifically intended for mass temperature screening in workplaces, public events, and social gatherings without contact to prevent contamination.

  • How far away should the thermometer be when taking a measurement?

    The device provides temperature readings within one second when held at an 8cm distance from the person or object being measured.

  • What safety and compatibility standards has this thermometer been tested to?

    The device has been tested to IEC 60601-1 and IEC 60601-1-2 standards for safety and electromagnetic compatibility.

  • What models are available for the Non-contact Forehead Thermometer?

    The device is supplied in various models including TH48FE, TH09F, and THD2FE, each designed for non-contact temperature measurement.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K240648 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 18 May 2026