YUWELL® Infrared Ear Thermometer

GUDID 06933257923133

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.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Infrared patient thermometer, ear

• Primary Device ID: 06933257923133
• NIH Device Record Key: 1091a3a1-0bc6-4c41-9768-9fff4d266698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL® Infrared Ear Thermometer
• Version Model Number: YHT100
• Company DUNS: 528704000
• Company Name: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933257923133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250878

FDA Product Code

• SDV: Clinical Electronic Thermometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [YUWELL® Infrared Ear Thermometer]

• 06933257930636: YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held,
• 06933257923133: YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held,