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Device Explorer · FDA GUDID · GMDN 17888

Infrared patient thermometer, skin

A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or varia

US‑registered devices934in commercial distribution
Companies162labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Guangzhou Berrcom Medical Device Co., Ltd9911%
Alicn Medical Shenzhen, Inc.768%
American Diagnostic Corp617%
Exergen Corporation556%
Dongguan Simzo Electronic Technology Co., Ltd.515%
Shenzhen Aoj Medical Technology Co., Ltd455%
Hetaida Technology Co., Ltd313%
Famidoc Technology Co.,Ltd.283%

Top labelers

CompanyDevicesShare
Guangzhou Berrcom Medical Device Co., Ltd9911%
Alicn Medical Shenzhen, Inc.768%
American Diagnostic Corp617%
Exergen Corporation556%
Dongguan Simzo Electronic Technology Co., Ltd.515%
Shenzhen Aoj Medical Technology Co., Ltd455%
Hetaida Technology Co., Ltd313%
Famidoc Technology Co.,Ltd.283%
Amplim, Llc273%
Kaz Usa, Inc.243%
Shenzhen Jumper Medical Equipment Co.,Ltd.192%
Visiomed Group192%

Company = labeler of record on GUDID. 162 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tyto DeviceYalomiCOMPEREQUATEFOXXDBytechMotorolaSoWeCareKINLee Non-contact Electronic Forehead Infrared QingyuanGROTINMIDERongfengInfrared ThermometerYASEEN/A

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, Clinical929
SDVClinical Electronic Thermometer133
HLJOphthalmoscope, Battery-Powered53
ERAOtoscope53
DXNSystem, Measurement, Blood-Pressure, Non-Invasive28
FLLContinuous Measurement Thermometer24

GMDN & GCC registration

  • GMDN code 17888 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 4% · OTC 51%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Centimeter) · 9Width (Centimeter) · 9Length (Centimeter) · 9Height (Millimeter) · 4Width (Millimeter) · 4Length (Millimeter) · 4

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

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

934 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infrared patient thermometer, skin", from 162 companies. The largest labeler is Guangzhou Berrcom Medical Device Co., Ltd with 11% of records.

Which FDA product codes apply?

FLL (Thermometer, Electronic, Clinical), SDV (Clinical Electronic Thermometer), HLJ (Ophthalmoscope, Battery-Powered), ERA (Otoscope)

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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