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iHealth Infrared No-Touch Forehead Thermometer

by Andon Health Co., Ltd.

510(k) K200531Ref PT2L

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K200531↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06930251800026 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06930251800026 Basic UDI-DI 06930251800026UDI-DIDate14 Jun 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK200531 Date15 Jul 2020ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Infrared Forehead Thermometer EUDAMED
Arrigo Professional Supplies LLC GUDID
Generic Name
Infrared patient thermometer, skin
Model / Reference
PT2L
FDA applicant
Andon Health Co, Ltd.
Primary DI / UDI-DI
06930251800026 EUDAMED
00850072625232 GUDID
Basic UDI-DI
B-06930251800026
510(k) Number
FDA Product Code
FLL
EMDN Code
V0301010202 Non-contact digital thermometers
GMDN Term
Infrared patient thermometer, skin
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 880.2910
EU market of registration
Spain
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Primary DI / UDI-DIEUDAMED
06930251800026
510(k)
—
GUDID
00850072625232
510(k) NumberEUDAMED
—
510(k)
K200531
GUDID
K200710
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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 iHealth Infrared No-Touch Forehead Thermometer is a non-contact infrared thermometer designed for rapid, contactless temperature measurement of the forehead. It falls under the category of thermometers intended for home or general hospital use, providing accurate readings without physical contact with the patient.

This device is supplied as a single-use or reusable unit, depending on the model variant, and is intended for use in both home and clinical settings. It is not MRI-safe and requires proper storage to maintain accuracy; no specific regulatory approvals beyond FDA 510(k) clearance and MDD compliance are stated. The device operates under the product code FLL and is authorized for distribution in accordance with the stated regulatory pathways.

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Properties

  • Measuring Function
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No