Tianjin Choice Medical Device Co., Ltd.

FDA Device Registration & Listing · Tianjin, CN · Registration 3015142815

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015142815
FEI Number
3015142815
Entity Name
Tianjin Choice Medical Device Co., Ltd.
City/State/Country
Tianjin, CN
Establishment Address
No. 6 Quanhe Road, Wuqing District Development Zone, Tianjin 301700, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Handheld ECG Monitor MD100A1-F Fingertip Pulse Oximeter MD300CN340R Fingertip Pulse Oximeter MD300CI218R Wrist Pulse Oximeter MD300W628 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 Fingertip Pulse Oximeter MD300CI218 Pulse Oximeter MD300M Pulse Oximeter MD300K2 Respiratory Trainer MD8000 Fingertip Pulse Oximeter HCSM70P Pulse Oximeter MD300CN330 Pulse Oximeter MD300CN340 Pulse Oximeter MD300CN150

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2012-08-06
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2021-11-22
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2018-02-27
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2022-10-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-01-26
DQA Oximeter Cardiovascular Class 2 870.2700 2008-08-27
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2010-05-10
DQA Oximeter Cardiovascular Class 2 870.2700 2018-10-30
DQA Oximeter Cardiovascular Class 2 870.2700 2024-06-28
DQA Oximeter Cardiovascular Class 2 870.2700 2009-03-09
NXQ Reminder, Medication Physical Medicine Class 1 890.5050 2015-06-02
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2014-05-18
DQA Oximeter Cardiovascular Class 2 870.2700 2016-06-14
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2013-06-20
DQA Oximeter Cardiovascular Class 2 870.2700 2013-11-20
DQA Oximeter Cardiovascular Class 2 870.2700 2013-11-20
DQA Oximeter Cardiovascular Class 2 870.2700 2023-03-13
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2010-04-02
DQA Oximeter Cardiovascular Class 2 870.2700 2023-09-05

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
3005569927 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BEIJING, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K862544 Suzuken Co., Ltd. KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH 1986-08-06
K802368 Marquette Electronics, Inc. OPTION 301 PACEMAKER EVAL. MODULE MAC-1 1981-03-04
K131503 Edan Instruments, Inc. SE-601 SERIES ELECTROCARDIOGRAPH 2014-02-25
K071802 Mammendorfer Institut Fur Physik Und Medizin GmbH TESLA GUARD, MODEL EFT G04 2007-11-09
K124061 Invivo Corporation MRI PATIENT MONITORING SYSTEM (MODEL 865214) 2013-02-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2022 Welch Allyn Inc Mortara 2
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012 Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China 2
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0001-2015 Invivo Corporation 2
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023 Philips North America Llc 2
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04 GE Medical Systems Information Technologies 2
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015142815. Last updated year: 2026. Please use registration number 3015142815 when referencing this establishment in official correspondence.
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