Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017493034

FEI Number

3017493034

Entity Name

Hetaida Technology Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province, Dongguan Guangdong 523423, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

HeTaiDa Technology Co., Ltd (Owner Number: 10058025)

Owner / Operator Contact Address

Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province, DongGuan, CN-GD 523423, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203332

PMA Number

N/A

All Registered Proprietary Names

Infrared Body Thermometer, model: HTD8222US Infrared Body Thermometer, model: HTD8219US Behind-the-Ear Hearing Aid, model: HTD6102US Upside Down Peri Bottle, Model: K5101US; Peri Bottle, Model: K5102US In-The-Ear Digital Hearing Aids, model: H6103US Electronic Blood Pressure Monitor, Model: D6606US, D6607US HTD8816C HTD8808C HTD8819C HTD8818A HTD8813C VNT275US VNT275USV1 VNT275CA VNT275CAV1 HTD8812C HTD8818D Infrared Body Thermometer, model: HTD8823US, K8832US, H8831US HTD8216C H8228US Electronic blood pressure monitor, model: HTD6601US; HTD6602US; HTD6603US; HTD6605US; D6606US; D6607US HTD2602US H2609AU NA-002 H2605US H2609US H2606US H2603US HTD2601US VIEK HTD8816C VTEK HTD8816C HTD8813C HTD8808C HTD8816C HTD8818A H8830US HTD8812C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-12-13
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2025-06-11
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2024-02-20
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2026-06-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-02-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-08-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-01-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-06-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-12-08
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2024-07-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-04-08

Official Correspondent

Tom Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HeTaiDa Technology Co., Ltd

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
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
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

Similar Registrations

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3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017493034. Last updated year: 2026. Please use registration number 3017493034 when referencing this establishment in official correspondence.