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Infrared Ear Thermometer

by Radiant Innovation Inc. Taiwan EUDAMED510(k)

Ref THR96JE, THP79JU, THR86JE, TH809S, THP86JEU, TH809J, TH709LE, TH819SJE, THi09Z, TH889S510(k) K030324 Product code FLLEMDN V0301010202

Regulatory status

as of 26 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)SESE 510(k) Substantially Equivalent · Special NumberK030324 Date27 Feb 2003ClearedStatusActive

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 24 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 24 Oct 2026

Device Name
Infrared Ear Thermometer
Model / Reference
THR96JE, THP79JU, THR86JE, TH809S, THP86JEU, TH809J, TH709LE, TH819SJE, THi09Z, TH889S
Primary DI / UDI-DI
04710810452987, 04710810452093, 04710810452772, 04710810451379, 04710810453380, 04710810451263, 04710810451409, 04710810452581, 04710810452000, 04710810452574
Basic UDI-DI
471081045IETE8
Direct Marketing DI
04710810452987
04710810452772
04710810453380
510(k) Number
FDA Product Code
FLL
EMDN Code
V0301010202 Non-contact digital thermometers
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 880.2910
Market of Registration
Northern Ireland
Italy
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

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 (11)

  • EUDAMED 35f3392f-c671-4f00-9fe2-e86d34cf4915 61 fields · synced 24 Oct 2026
  • EUDAMED 04710810452093|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810452772|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810451379|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810453380|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810451263|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810451409|471081045IETE8 61 fields · synced 17 May 2026
  • EUDAMED 04710810452581|471081045IETE8 61 fields · synced 18 May 2026
  • EUDAMED 04710810452000|471081045IETE8 61 fields · synced 18 May 2026
  • FDA 510(k) K030324 24 fields · synced 18 May 2026
  • EUDAMED 04710810452574|471081045IETE8 61 fields · synced 28 Jul 2026