Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019470217

FEI Number

3019470217

Entity Name

Guangzhou Daxin Health Technology (Dongguan) Co., Ltd

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Room 601, Building 3, No. 9, Jinshagang Road 1, Dalang Town, Dongguan City Guangdong 523792, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Daxin Health Technology Co., Ltd (Owner Number: 10081835)

Owner / Operator Contact Address

Room 510, Building A02, Guangzhou Knowledge City International Leading Talent Agglomeration Area, No. 5 Suike Street, Huangpu District, Guangzhou, CN-GD 510530, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140681

PMA Number

N/A

All Registered Proprietary Names

Blood Pressure Meter MS1 Fingertip Pulse Oximeter Body Composition Scale EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-916B4,eF-706B4S,eF-918B4PL,eF-917B4P,eF-804B4P,eF-919B4,eF-919B4S,T9140 eF-804B4P-Tuya,eF-916B4S,eF-919B4P,eF-919B4SP,eF-706W,eF-804W,GN-WA005-199,eF-654W,eF-655W,eF-670W,eF-802W,eF-803W,eF-805W eF-806W,eF-807W,eF-916W,eF-917W,eF-918W,eF-917WP,WW390XF,Koogeek-S1,WW390F,SF-371,S-3 EF-803B4,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-917B4,eF-914B4P,eF-712B4,eF-671B4,eF-918B4P,eF-918B4SP,eF-804B4SP BFS1 LAH5CB4-BT Thermometer MT1, TE-66

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-12-05
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2021-05-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Guangzhou Daxin Health 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019470217. Last updated year: 2026. Please use registration number 3019470217 when referencing this establishment in official correspondence.