Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015542362

FEI Number

3015542362

Entity Name

SHENZHEN BSX TECHNOLOGY ELECTRONICS CO.,LTD

City/State/Country

Shen Zhen Guangdong, CN

Establishment Address

Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen, Shen Zhen Guangdong 518116, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen BSX Technology Electronics Co.,Ltd (Owner Number: 10060909)

Owner / Operator Contact Address

Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen, Shen Zhen, CN-GD 518116, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202324

PMA Number

N/A

All Registered Proprietary Names

Arm-Type Electronic Blood Pressure Monitor Moderl BSX5035 Arm-Type Electronic Blood Pressure Monitor Moderl BSX515 Arm-Type Electronic Blood Pressure Monitor Moderl BSX580 Arm-Type Electronic Blood Pressure Monitor Moderl BSX556 Arm-Type Electronic Blood Pressure Monitor Moderl BSX532 Arm-Type Electronic Blood Pressure Monitor Moderl BSX553 Arm-Type Electronic Blood Pressure Monitor Moderl BSX558 Arm-Type Electronic Blood Pressure Monitor Moderl BSX573 Arm-Type Electronic Blood Pressure Monitor Moderl BSX593 Arm-Type Electronic Blood Pressure Monitor Moderl BSX568 Arm-Type Electronic Blood Pressure Monitor Moderl BSX595 Arm-Type Electronic Blood Pressure Monitor Moderl BSX595 SMART Arm-Type Electronic Blood Pressure Monitor Moderl BSX505 Arm-Type Electronic Blood Pressure Monitor Moderl BSX525 Arm-Type Electronic Blood Pressure Monitor Moderl BSX527 Arm-Type Electronic Blood Pressure Monitor Moderl BSX593 SMART Arm-Type Electronic Blood Pressure Monitor Moderl BSX523 Arm-Type Electronic Blood Pressure Monitor Moderl BSX583 Arm-Type Electronic Blood Pressure Monitor Moderl BSX579 Arm-Type Electronic Blood Pressure Monitor Moderl BSX516 Arm-Type Electronic Blood Pressure Monitor Moderl BSX513 Arm-Type Electronic Blood Pressure Monitor Moderl BSX561 Arm-Type Electronic Blood Pressure Monitor Moderl BSX5113 Arm-Type Electronic Blood Pressure Monitor Moderl BSX5125 Arm-Type Electronic Blood Pressure Monitor Moderl BSX5826 IPL Hair Removal Device Model HYU0-G602 IPL Hair Removal Device Model BSXT106 IPL Hair Removal Device Model BSXT101 IPL Hair Removal Device Model BSXT103 IPL Hair Removal Device Model BSXT102 IPL Hair Removal Device Model YT301 Fingertip Pulse Oximeter Model BSX231 Fingertip Pulse Oximeter Model BSX233 Fingertip Pulse Oximeter Model BSX253 Infrared Thermometer BSX916 Infrared Thermometer BSX976 Fingertip Pulse Oximeter Model BSX251

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	2019-07-11
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-04-17
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2021-02-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-08-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-19

Official Correspondent

Kai Fang

US Agent Details

Robin Zhang Business: CTI US lnc. Email: robin.zhang@cti-cert.com Phone: (313) 2885666

Related Public Records

Same Entity

Shenzhen BSX Technology Electronics 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 3015542362. Last updated year: 2026. Please use registration number 3015542362 when referencing this establishment in official correspondence.