Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043047278

FEI Number

3043047278

Entity Name

SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, China, Shenzhen Guangdong 518102, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Hingmed Medical Instrument Co., Ltd (Owner Number: 10095417)

Owner / Operator Contact Address

4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, China, Shenzhen, CN-GD 518102, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231984

PMA Number

N/A

All Registered Proprietary Names

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP)

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	2026-03-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-11

Official Correspondent

Hingmed Zhang

US Agent Details

James Wang Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Shenzhen Hingmed Medical Instrument 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.

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 3043047278. Last updated year: 2026. Please use registration number 3043047278 when referencing this establishment in official correspondence.