Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013510081

FEI Number

3013510081

Entity Name

GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD

City/State/Country

ZHONGSHAN Guangdong, CN

Establishment Address

NUMBER 42, CUICHENG ROAD, CUIHENG NEW DISTRICT, ZHONGSHAN Guangdong 528400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD (Owner Number: 10054235)

Owner / Operator Contact Address

NUMBER 42, CUICHENG ROAD, CUIHENG NEW, DISTRICT, ZHONGSHAN, CN-GD 528400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241634

PMA Number

N/A

All Registered Proprietary Names

XY-6711 XY-6010 XY-6705 XY-6701 XY-6702 XY-6706 BF180, BF179, ES-32MD XY-6168 XY-6169,XY-6169-BO XY-6061-BO,XY-6025 XY-6027 XY-6029 XY-6030 XY-6031 XY-6032 XY-6033 XY-6035 XY-6010 XY-6012 XY-6013 XY-6015A XY-6015B XY-6016 XY-6026 XY-6028 XY-6039 XY-6051 XY-6052 XY-6055 XY-6058 XY-M01B, XY-6110, XY-6112, XY-6103, XY-6101, XY-6008, XY-6009, XY-6107, XY-6109 XY-6079 XY-6080 XY-6081 XY-6082 XY-6085 XY-6086 XY-6088 XY-6089 XY-6090 XY-6091 XY-6092 XY-6093 XY-6095 XY-6061 XY-6063 XY-6065 XY-6066 XY-6068 XY-6069 XY-6069N XY-6070 XY-6071 XY-6073 XY-6075 XY-6076 XY-6078 Arm Blood Pressure Monitor, XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09 Wrist Blood Pressure Monitor, XY-W01A, XY-W01B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2019-01-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-02-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-02-16

Official Correspondent

Rita Long

US Agent Details

Terry Chai Business: TJ Chai Investment LLC Email: terry.chai.nj@hotmail.com Phone: (908) 6361278

Related Public Records

Same Entity

GUANGDONG XINYU ELECTRONIC AND 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.

Similar Registrations

Registration Number	Establishment Name	Location
3044921217	SHANGHAI YOUJOY HEALTH TECHNOLOGY CO., LTD.	shanghai, CN
3006026335	Shenzhen Shine Industrial Co., Ltd.	Shenzhen Guangdong, CN
3012094189	BIOTEKNA SRL	Marcon Veneto, IT
3007695022	Guangdong Winburg Technology Co.,Ltd	ZHONGSHAN Guangdong, CN
3006624940	SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013510081. Last updated year: 2026. Please use registration number 3013510081 when referencing this establishment in official correspondence.