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Device Explorer · FDA GUDID · GMDN 17887

Infrared patient thermometer, ear

A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory

US‑registered devices243in commercial distribution
Companies81labelers on GUDID
Single‑use6%of device records
Sterile1%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Kaz Usa, Inc.2611%
Shenzhen Belter Health Measurement And Analysis Technology Co., Ltd.219%
Dorel Juvenile Group, Inc.167%
Shenzhen Brav Electronic Technologies Co., Ltd.104%
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.94%
Fora Care Inc.94%
Woonsocket Prescription Center, Incorporated94%
Famidoc Technology Co.,Ltd.62%

Top labelers

CompanyDevicesShare
Kaz Usa, Inc.2611%
Shenzhen Belter Health Measurement And Analysis Technology Co., Ltd.219%
Dorel Juvenile Group, Inc.167%
Shenzhen Brav Electronic Technologies Co., Ltd.104%
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.94%
Fora Care Inc.94%
Woonsocket Prescription Center, Incorporated94%
Famidoc Technology Co.,Ltd.62%
Rudolf Riester Gmbh62%
Amico Diagnostic Incorporated62%
Walgreen Co.62%
Avita Corporation52%

Company = labeler of record on GUDID. 81 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

COMPERActhermTizziorREFAGOFamidochetaidaFDKAUPOFANMIFANMI Infrared ThermometerAEONBPRYCOMEquateBytechThermometer

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FLLThermometer, Electronic, Clinical231
SDVClinical Electronic Thermometer21
FLLThermometer, electronic, clinical19
FLLContinuous Measurement Thermometer11
ERAOtoscope6
HLIOphthalmoscope, Ac-Powered6

GMDN & GCC registration

  • GMDN code 17887 · non‑implantable
  • Single‑use 6% · sterile 1% · Rx‑only 5% · OTC 46%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 2Length (Millimeter) · 2Width (Millimeter) · 2Height (Millimeter) · 2Weight (Pound) · 1

Use these as the dimensions to specify in a tender line.

How many infrared patient thermometer, ear products are registered in the US?

243 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infrared patient thermometer, ear", from 81 companies. The largest labeler is Kaz Usa, Inc. with 11% of records.

Which FDA product codes apply?

FLL (Thermometer, Electronic, Clinical), SDV (Clinical Electronic Thermometer), FLL (Thermometer, electronic, clinical), FLL (Continuous Measurement Thermometer)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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