YUWELL® Infrared Ear Thermometer

GUDID 06933257930636

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.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Infrared patient thermometer, ear

• Primary Device ID: 06933257930636
• NIH Device Record Key: 0a3fe0c7-125b-480f-8ca7-eb7a2dc29395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL® Infrared Ear Thermometer
• Version Model Number: YHT107
• 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	06933257930636 [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,