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Device Explorer · FDA GUDID · GMDN 63711

Infrared patient thermometer, ear/skin

A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement o

US‑registered devices108in commercial distribution
Companies32labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Shenzhen Finicare Co., Ltd1716%
Shenzhen Urion Technology Co., Ltd1716%
Sevenground Trading B.V.98%
Alicn Medical Shenzhen, Inc.87%
Kangfu Medical Equipment Factory87%
Shenzhen Aoj Medical Technology Co., Ltd55%
Shenzhen Pacom Medical Instruments Co., Ltd.44%
Conair Corporation44%

Top labelers

CompanyDevicesShare
Shenzhen Finicare Co., Ltd1716%
Shenzhen Urion Technology Co., Ltd1716%
Sevenground Trading B.V.98%
Alicn Medical Shenzhen, Inc.87%
Kangfu Medical Equipment Factory87%
Shenzhen Aoj Medical Technology Co., Ltd55%
Shenzhen Pacom Medical Instruments Co., Ltd.44%
Conair Corporation44%
Shenzhen Jumper Medical Equipment Co.,Ltd.33%
Shenzhen Everbest Machinery Industry Co., Ltd.33%
Shenzhen Pango Electronic Co., Ltd.33%
Uni-Trend Technology (China) Co., Ltd.33%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Infrared thermometerMinttiYASEETizziorN/ADrBashSimpliCareFinicareVIGORUNhetaidaALPHAMEDAoeomkonsungSmilecareFIGHTECHHUHETA

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, Clinical95
FLLContinuous Measurement Thermometer9
SDVClinical Electronic Thermometer6

GMDN & GCC registration

  • GMDN code 63711 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 0% · OTC 44%
  • 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) · 1Width (Centimeter) · 1Length (Centimeter) · 1

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

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

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infrared patient thermometer, ear/skin", from 32 companies. The largest labeler is Shenzhen Finicare Co., Ltd with 16% of records.

Which FDA product codes apply?

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