Mothermed

FDA UDI

Class II (US FDA UDI)

by Famidoc Technology Company Limited

Identity

Trade Name: Mothermed FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: This thermometer is intended for non-contact to measurement of forehead temperature at home or hospital for anyone,forehead temperature measurement is suitable for the human body, can also be used to measure surface temperature. FDA UDI
Model / Reference: IR122 FDA UDI
Description: This thermometer is intended for non-contact to measurement of forehead temperature at home or hospital for anyone,forehead temperature measurement is suitable for the human body, can also be used to measure surface temperature. FDA UDI

Identifiers

Primary DI / UDI-DI: 00818218021225 FDA UDI
510(k) Number: K113761 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Infrared patient thermometer, skin

Mothermed by Famidoc Technology Company Limited — 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
DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II
BBLOVE Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II

Cleared under the same submission

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: Famidoc Technology Company Limited

Sources (1)

FDA UDI fc719b82-a1fa-4108-baa4-9347068dd4a0 34 fields · synced Jun 8, 2026