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Infrared Ear Thermometer

by Radiant Innovation Inc. Taiwan EUDAMED510(k)

Ref TH809 EMDN V0301010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberTW24/00000261 Date10 Jul 2024IssuedStatusWithdrawn Not intended for the EU market expires 26 Mar 2029
United StatesFDA 510(k) 510(k) NumberK111637 Date6 Dec 2011IssuedStatusActive

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TW24/00000261 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    10 Jul 2024
    Expires
    26 Mar 2029
    Reason
    Change approved

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

Device Name
Infrared Ear Thermometer
Model / Reference
TH809
Primary DI / UDI-DI
04710810450013
Basic UDI-DI
471081045IETE8
EMDN Code
V0301010202 Non-contact digital thermometers
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
TW-MF-000007935
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Radiant Innovation Inc.

See all devices from Radiant Innovation Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 3b7de41a-7729-4900-83d1-f0f1b93c94c7 61 fields · synced 25 Oct 2026
  • FDA 510(k) K111637 1 fields · synced 18 May 2026