YUWELL Infrared Thermometer

FDA UDI

Class II (US FDA UDI)

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Identity

Trade Name: YUWELL Infrared Thermometer FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies. FDA UDI
Model / Reference: YT-1 FDA UDI
Description: The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies. FDA UDI

Identifiers

Primary DI / UDI-DI: 06933257922747 FDA UDI
510(k) Number: K201864 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Infrared patient thermometer, skin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Infrared patient thermometer, skin

YUWELL Infrared Thermometer by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

TytoHome — TYTO CARE LTD · Class II
ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
Diagnostix™ — American Diagnostic Corporation · Class II
Famidoc — FAMIDOC USA, INC. · Class II
Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Famidoc — Famidoc Technology Company Limited · Class II
DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II

Cleared under the same submission

K201864 also covers:

CARDINAL HEALTH — Cardinal Health 200, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Sources (1)

FDA UDI c8f5951f-bf60-49f1-9c34-c9499ccbfb6c 34 fields · synced May 31, 2026