Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026032283

FEI Number

3026032283

Entity Name

SHENZHEN HETAIDA TECHNOLOGY LIMITED COMPANY

City/State/Country

Shenzhen City Guangdong, CN

Establishment Address

Room 2209, Tower A, CR Land Qianhai Building, No.5035 Menghai Ave., Nanshan District, Shenzhen City Guangdong 518052, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Hetaida Technology Limited Company (Owner Number: 10087194)

Owner / Operator Contact Address

Room 2209, Tower A, CR Land Qianhai Building, No.5035 Menghai Ave., Nanshan District, Shenzhen City, CN-GD 518052, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instant Ice Maxi Pads, Postpartum lce Pack Pads Non-Contact Infrared Body Thermometer Non-Contact Infrared Body Thermometer Infrared Ear Thermometer, Model: HTD8208C Infrared Body Thermometer, Model: HTD8220US Postpartum Catch-All Pads, Postpartum Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-05-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-01-24
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-02-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-05-05
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-05-05

Official Correspondent

Happy Tan

US Agent Details

Hui Hong Business: ABMED SERVICE INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Shenzhen Hetaida Technology Limited Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026032283. Last updated year: 2026. Please use registration number 3026032283 when referencing this establishment in official correspondence.