FDA.reportPublic FDA data

YUWELL® Infrared Ear Thermometer

Primary DI
06933257930636
Brand
YUWELL® Infrared Ear Thermometer
Company
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Model
YHT107
Device description
YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held, no-contact device is battery-powered and utilizes infrared energy emitted in the subject’s tympanic membrane to determine human body temperature. The thermometer provides temperature readings in just 2 seconds. It is suitable for individuals of all ages except preterm babies or babies who are small for gestational age. The Infrared Ear Thermometer YHT107 can transmit the temperature readings via Bluetooth.
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250878000YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-05-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06933257930636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06933257930636069332579306366933257930636

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528704000
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06933257920187Electronic Blood Pressure MonitorYE650AR2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorYE630CR2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorYE8800AR2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorYE660D PRO2026-10-09
06933257947023Electronic Blood Pressure MonitorYE660E PRO2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorYE680B PRO2026-10-09
06933257923157YUWELL® Infrared ThermometerYT-32026-08-19
06933257952744YUWELL® Infrared ThermometerYHW-62026-08-19
06933257952751YUWELL® Infrared ThermometerYHW-52026-08-19
06933257929432YUWELL® Infrared Ear ThermometerYHT108YHT1080012026-05-07
06933257930711YUWELL® Infrared Ear ThermometerYHT208YHT2080012026-05-07
06933257931213YUWELL® Infrared Ear ThermometerYHT202YHT2020012026-05-07
06933257931244YUWELL® Infrared Ear ThermometerYHT108YHT1080022026-05-07
06933257931251YUWELL® Infrared Ear ThermometerYHT202YHT2020022026-05-07
06933257931268YUWELL® Infrared Ear ThermometerYHT208YHT2080022026-05-07
06933257922006YUWELL® Finger Pulse OximeterYX1102026-05-06
06933257922013YUWELL® Finger Pulse OximeterYX3102026-05-06
06933257923171YUWELL® Finger Pulse OximeterYX1052026-05-06
06933257923188YUWELL® Finger Pulse OximeterYX1062026-05-06
06933257948488YUWELL Portable Oxygen ConcentratorSP-32026-02-24

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Primary DI, Brand, Company table
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00810110303812NuvomedNUVOMED, INC.SDV2026-08-19
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06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
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