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

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA 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 canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

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
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
06933257923133YUWELL® Infrared Ear ThermometerYHT1002025-09-05
06933257921948YUWELL®Finger Pulse OximeterYX1022025-06-16
06933257921955YUWELL® Finger Pulse OximeterYX1032025-06-16
06933257921993YUWELL® Finger Pulse OximeterYX3062025-06-16
06933257916593YUWELL Electronic Blood Pressure MonitorYE660F2025-06-12
06933257921634YUWELL Electronic Blood Pressure MonitorYE8800AR2025-06-12
06933257935419InogenVoxi 52025-06-11
06933257924925YUWELL Portable Oxygen ConcentratorSpirit-32025-06-10
06933257914124YUWELL Electronic Blood Pressure MonitorYE620B2025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015688927HomedicsFKA DISTRIBUTING CO., LLCSDV2026-05-31
06933257929432YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257930711YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931213YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931244YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931251YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931268YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
10840330706558ProCureTwin Med, LLCSDV2026-05-05
10840330706565ProCureTwin Med, LLCSDV2026-05-05
00860015673107Inito InTemp Basal ThermometerInito Health, Inc.SDV2026-04-08
06953775662345BBLOVEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662369AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662383AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
04719003406516MicrolifeMICROLIFE USA, INC.SDV2026-01-31
04719883871350Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871374Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871381Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871435Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883870070ForeHealthFORTECHGRP CO., LTD.SDV2026-01-26
00194346614042EquateWAL-MART STORES, INC.SDV2026-01-21
06947656117932BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118014BerrcomGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118021DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118038DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118045DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118052BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
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00850044118700iHealthiHealth Labs Inc.SDV2025-12-19
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00860013187774PLAYHOUSE MDPLAYHOUSE METHOD INC.SDV2025-12-17