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Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

by Guandong Genial Technology Co., Limited

510(k) K210014

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210014↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210014 Date4 Jun 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Infrared Forehead Thermometer (Models T80, T81, T82, T83, T84, T85) is a non-contact, infrared-based device designed to measure core body temperature via the temporal artery region of the forehead. It operates by detecting infrared radiation emitted from the skin, converting it into an accurate digital temperature reading within seconds, and is classified under the general hospital category for clinical use.

These thermometers are intended for single-use or reusable applications in healthcare settings, depending on the model variant, and are supplied sterile or non-sterile as specified by the manufacturer. They comply with FDA 510(k) clearance under the Traditional pathway and are also authorized under the EU Medical Device Regulation (MDR). Models are available in various configurations, with temperature readings displayed digitally for ease of use, and are intended for use in environments requiring rapid, non-invasive temperature assessment.