Infrared Body Thermometer

FDA UDIEUDAMED

Class II (US FDA UDI)

by Hetaida Technology Co., Ltd

Identity

Trade Name: Infrared Body Thermometer FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Model / Reference: HTD8216C FDA UDI

Identifiers

Primary DI / UDI-DI: 06970289030002 FDA UDI
510(k) Number: K180385 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

Dimensions & Sizes

Size: Height — 52 Centimeter FDA UDI
Width — 34 Centimeter FDA UDI
Length — 154 Centimeter FDA UDI

Category: Infrared patient thermometer, skin

Infrared Body Thermometer by Hetaida Technology Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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

K180385 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hetaida Technology Co., Ltd

Sources (2)

FDA UDI f04d7c4e-96df-4b2f-9817-1a284dda5930 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 2, 2026