THERMOQUICK - Thermocare

FDA UDI

Class II (US FDA UDI)

by T&R Biofab Co., Ltd

Identity

Trade Name: THERMOQUICK; THERMOCLICK; THERMOCARE FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: THERMOQUICK is a battery-powered, non-contact infrared thermometer intended to be used to monitor the body temperature of people of all ages. The reference body site of the output temperature is the axilla. A sensor built into the product measures the infrared energy emitted from the skin surface of the forehead within 2cm, so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages. FDA UDI
Model / Reference: MT-3000 FDA UDI
Description: THERMOQUICK is a battery-powered, non-contact infrared thermometer intended to be used to monitor the body temperature of people of all ages. The reference body site of the output temperature is the axilla. A sensor built into the product measures the infrared energy emitted from the skin surface of the forehead within 2cm, so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages. FDA UDI

Identifiers

Catalog Number: MT-3000 FDA UDI
Primary DI / UDI-DI: 08800065226726 FDA UDI
510(k) Number: K222057 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Infrared patient thermometer, skin FDA UDI
Models / Variants: Thermoquick FDA UDI
Thermoclick FDA UDI
Thermocare 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, skin

THERMOQUICK - Thermocare by T&R Biofab Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

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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

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: T&R Biofab Co., Ltd

Sources (1)

FDA UDI 2106799e-43d4-4909-8ca1-2dc629d763a7 36 fields · synced Jun 8, 2026