Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005569927

FEI Number

3005569927

Entity Name

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.

City/State/Country

BEIJING, CN

Establishment Address

No.9 Shuangyuan Road, Badachu Hi-tech Zone,, Shijingshan District, BEIJING 100041, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. (Owner Number: 9106400)

Owner / Operator Contact Address

2nd and 3rd Floors, No. 2 Building, No. 9 Shuangyuan Road, Shijingshan District, BEIJING, CN-BJ 100041, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Respiratory Trainer MD8000 Cooling Gel Patch CCGP1A1 Fingertip Pulse Oximeter HCSM70P Arm type Blood Pressure Monitor CBP1K1 Arm type Blood Pressure Monitor CBP1K3 Arm type Blood Pressure Monitor CBP1K2 One Step LH Urine Ovulation Test Strip Handheld ECG Monitor MD100A1-F Pulse Oximeter MD300CN330 Pulse Oximeter MD300CN340 Pulse Oximeter MD300CN150 Knee Support CKS1A1 Elbow Support CES1A1 Fingertip Pulse Oximeter MD300CN340 Fingertip Pulse Oximeter MD300CN160 Wrist Pulse Oximeter MD300W628 Fingertip Pulse Oximeter MD300C26 Fingertip Pulse Oximeter OxyWatch C15F Fingertip Pulse Oximeter MD300CN330 Fingertip Pulse Oximeter MD300C56 Fingertip Pulse Oximeter OxyWatch C1F Fingertip Pulse Oximeter OxyWatch C15D Fingertip Pulse Oximeter OxyWatch C18 Fingertip Pulse Oximeter MD300CN140 Fingertip Pulse Oximeter MD300C1C Fingertip Pulse Oximeter MD300C55 Pulse Oximeter MD300CI218R Fingertip Pulse Oximeter MD300CN368R Fingertip Pulse Oximeter MD300C53 Fingertip Pulse Oximeter MD300C57 Fingertip Pulse Oximeter MD300C15F Pulse Oximeter MD300M Pulse Oximeter MD300K2 Digital Blood Pressure Monitor BP11 Digital Blood Pressure Monitor BP10 Stocking, Elastic CKT1A1 Fingertip Pulse Oximeter MD300CI218 Digital Blood Pressure Monitor-Wrist Style CBP2K3 Digital Blood Pressure Monitor-Wrist Style CBP2K2 Digital Blood Pressure Monitor-Wrist Style CBP2K1 Fingertip Pulse Oximeter MD300C2 Fingertip Pulse Oximeter MD300CN340 Fingertip Pulse Oximeter MD300C13 Fingertip Pulse Oximeter MD300C5 Fingertip Pulse Oximeter MD300C29 Fingertip Pulse Oximeter MD300C21C Fingertip Pulse Oximeter MD300C53 Fingertip Pulse Oximeter MD300C20 Fingertip Pulse Oximeter MD300C55 Fingertip Pulse Oximeter MD300C26 Fingertip Pulse Oximeter MD300C63 Fingertip Pulse Oximeter MD300CN340R Fingertip Pulse Oximeter MD300CI218R Wrist Pulse Oximeter MD300W628

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2013-06-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-08-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-03-14
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-07-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-11-20
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-01-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-09-10
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2015-06-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-08-21
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2015-06-02
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2015-05-25
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-08-06
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2015-06-01
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2015-06-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-11-01
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2017-11-03
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-11-03
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-11-03
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2017-11-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2016-05-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-01-18
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2018-10-29
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-03-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-03-13
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2014-05-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-04-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-07-20
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2016-09-09
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2010-05-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-06-14
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-06-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-06-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-11-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2016-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-11-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-01-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-08-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-09-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-06-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-09-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-10-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-02-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-07-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-05-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-03-09
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2018-02-27

Official Correspondent

Li Zhang

US Agent Details

Paul Gao Business: ChoiceMMed America Corporation Email: paul@choicemmedamerica.com Phone: (703) 8804154

Related Public Records

Same Entity

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015142815	Tianjin Choice Medical Device Co., Ltd.	Tianjin, CN

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005569927. Last updated year: 2026. Please use registration number 3005569927 when referencing this establishment in official correspondence.