Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006979678

FEI Number

3006979678

Entity Name

CONTEC MEDICAL SYSTEMS CO., LTD

City/State/Country

Qinhuangdao Hebei, CN

Establishment Address

No.112 Qinhuang West Street, Economic and Technical Development Zone, Qinhuangdao Hebei 066004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CONTEC MEDICAL SYSTEMS CO., LTD (Owner Number: 10025156)

Owner / Operator Contact Address

No.112 Qinhuang West Street, Economic and Technical Development Zone, Qinhuangdao, CN-HE 066004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101692

PMA Number

N/A

All Registered Proprietary Names

CONTEC08A Electronic Sphygmomanometer PM10 Portable ECG Monitor CMS600P2PLUS B-Ultrasound Diagnostic System CONTEC08E Electronic Sphygmomanometer CONTEC08C Electronic Sphygmomanometer PM50 Patient Monitor CMS1700B Color Doppler Ultrasound Diagnostic System CMS1700C Color Doppler Ultrasound Diagnostic System Urine Analyzer CONTEC10CL Pocket Fetal Doppler CONTEC10C Pocket Fetal Doppler CMS600P2 B-Ultrasound Diagnostic System NE-M03F Medicinal Nonventilatory Nebulizer NE-M03 Medicinal Nonventilatory Nebulizer(Atomizer) CMS50Q1 Pulse Oximeter PM10 Portable ECG Monitor MQ3200 Pulse Oximeter PO250D Pulse Oximeter CMS50DL Pulse Oximeter CMS50D1A Pulse Oximeter CMS50F Pulse Oximeter CMS50DL1 Pulse Oximeter CMS50M Pulse Oximeter CMS50NA Pulse Oximeter CMS50DA Pulse oximeter CMS50-Pro Pulse Oximeter MQ3000 Pulse Oximeter ABPM50 Automatic Blood Pressure Monitors CMS50I Pulse Oximeter CMS50F Pulse Oximeter TLC5000 Dynamic ECG Systems SC11 Stethoscope SC21 Stethoscope SC22 Stethoscope SC12 Stethoscope SC23 Stethoscope SC12Q Stethoscope SC23C Stethoscope SC32 Stethoscope SC23Q Stethoscope SC23P Stethoscope CMS8000 Patient Monitor

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	2011-05-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2016-06-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-05-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-05-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-05-22
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-06-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-05-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-05-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-05-06
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-03-25
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2022-10-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-11-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-11-20
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2025-08-08
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2015-09-15
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-04
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2014-11-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-07-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-06-29
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2011-11-16
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2021-07-25
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2011-06-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-06-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-06-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2011-06-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-06-30
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2011-06-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-06-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2011-06-30
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2011-06-30

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Xu Email: Info@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

CONTEC MEDICAL SYSTEMS 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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006979678. Last updated year: 2026. Please use registration number 3006979678 when referencing this establishment in official correspondence.