Contec Medical Systems Co., Ltd.
Manufacturer and brand owner in Qinhuangdao, Hebei, China. 22 device types, 29 products catalogued, 12 clearances.
Contec Medical Systems Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Electrocardiograph and 20 other device types. 29 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
22device types registered with the FDA
29products catalogued under its own name
12510(k) clearances
1recall
Registration
| Registered name | CONTEC MEDICAL SYSTEMS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006979678 |
| FEI number | 3006979678 |
| DUNS | 529606295 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 秦皇岛市康泰医学系统有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Qinhuangdao |
|---|---|
| Province | Hebei |
| Address | No.112 Qinhuang West Street |
| Postal code | 066004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | CMS8000 Patient Monitor | 2011 | 29 |
| Automated Urinalysis System | Class 1 | Urine Analyzer | 2015 | 16 |
| Computer, Blood-Pressure | Class 2 | CMS8000 Patient Monitor | 2011 | 12 |
| Continuous Measurement Thermometer | Class 2 | TP600 Infrared Thermometer, CMS8000 Patient Monitor | 2011 | 115 |
| Detector And Alarm, Arrhythmia | Class 2 | CMS8000 Patient Monitor | 2011 | 10 |
| Electrocardiograph | Class 2 | ECG300G Electrocardiograph, ECG100G Electrocardiograph, ECG1200G Electrocardiograph, PM10 Portable ECG Monitor, ECG90A Electrocardiograph | 2014 | 18 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | Class 2 | TLC5000 Dynamic ECG Systems | 2011 | 2 |
| Monitor, Breathing Frequency | Class 2 | CMS8000 Patient Monitor | 2011 | 8 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | CMS8000 Patient Monitor | 2011 | 9 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | PM50 Patient Monitor | 2010 | 17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | CMS8000 Patient Monitor | 2011 | 9 |
| Monitor, St Segment With Alarm | Class 2 | CMS8000 Patient Monitor | 2011 | 7 |
| Monitor, Ultrasonic, Fetal | Class 2 | Baby Sound C Pocket Fetal Doppler, 2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;, Baby Sound B Pocket Fetal Doppler, Sonoline B Pocket Fetal Doppler, Sonoline A Pocket Fetal Doppler, Baby Sound A Pocket Fetal Doppler and 3 more | 2009 | 13 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | NE-M03F Medicinal Nonventilatory Nebulizer, NE-M03 Medicinal Nonventilatory Nebulizer(Atomizer) | 2025 | 57 |
| Oximeter | Class 2 | CMS50I Pulse Oximeter, CMS50F Pulse Oximeter, CMS8000 Patient Monitor, CMS50DA Pulse Oximeter, CMS50DL Pulse Oximeter | 2008 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | PO250D Pulse Oximeter, CMS50-Pro Pulse Oximeter, CMS50NA Pulse Oximeter, CMS50DA Pulse oximeter, CMS50DL1 Pulse Oximeter, CMS50F Pulse Oximeter and 5 more | 2014 | 29 |
| Oximeter, Wellness | Class 2 | CMS50Q1 Pulse Oximeter | 2015 | 19 |
| Stethoscope, Manual | Class 1 | SC12Q Stethoscope, SC22 Stethoscope, SC23C Stethoscope, SC12 Stethoscope, SC11 Stethoscope, SC23Q Stethoscope and 4 more | 2021 | 64 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | CMS1700C Color Doppler Ultrasound Diagnostic System, CMS1700B Color Doppler Ultrasound Diagnostic System | 2024 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | CMS600P2 B-Ultrasound Diagnostic System, CMS1700C Color Doppler Ultrasound Diagnostic System, CMS1700B Color Doppler Ultrasound Diagnostic System, CMS600P2PLUS B-Ultrasound Diagnostic System | 2017 | 37 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | CONTEC08A Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitors, CONTEC08C Electronic Sphygmomanometer, CONTEC08E Electronic Sphygmomanometer, CMS8000 Patient Monitor, ABPM50 Automatic Blood Pressure Monitor | 2011 | 98 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | CMS600P2 B-Ultrasound Diagnostic System, CMS1700C Color Doppler Ultrasound Diagnostic System, CMS1700B Color Doppler Ultrasound Diagnostic System, CMS600P2PLUS B-Ultrasound Diagnostic System | 2017 | 44 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Contec | OCH | 21 |
| Contec | DQA | 21 |
| Concord | OCH | 12 |
| Contec | PGJ | 11 |
| Contec | KNG | 10 |
| Contec | DPS | 8 |
| Contec | DXN | 8 |
| Contec | LDE | 3 |
| Contec | MLO | 3 |
| Contec | IYN | 2 |
| TytoCare Pulse Oximeter | DQA | 2 |
| Contec | IYO | 2 |
| Contec | CAW | 2 |
| Contec | CCQ | 2 |
| Contec | BZQ | 2 |
| Sunbeam | OCH | 2 |
| TytoCare Pulse Oximeter | PGJ | 1 |
| Contec | FRI | 1 |
| Contec | MLD | 1 |
| Contec | KQO | 1 |
| Contec | JJE | 1 |
| SimbR | PGJ | 1 |
| WilBee | PGJ | 1 |
| Contec | MWI | 1 |
| Contec | JMA | 1 |
| Santamedical | OCH | 1 |
| Contec | FLL | 1 |
| Nova | DQA | 1 |
| Contec | KZD | 1 |
Clearances
12 clearances name Contec Medical Systems Co., Ltd. as applicant. 9 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232893 | 2024-06-14 | KNG | Traditional | This company |
| K232895 | 2024-05-03 | IYO | Traditional | This company |
| K232908 | 2024-05-02 | IYN | Traditional | This company |
| K220245 | 2022-09-28 | KNG | Traditional | This company |
| K202757 | 2021-04-28 | DXN | Traditional | This company |
| K201980 | 2020-12-18 | FLL | Traditional | This company |
| K171360 | 2018-01-22 | DPS | Traditional | This company |
| K170856 | 2017-11-17 | IYO | Traditional | This company |
| K170954 | 2017-05-30 | DPS | Traditional | This company |
| K152863 | 2016-06-22 | DPS | Traditional | This company |
| K141362 | 2015-04-23 | DQA | Traditional | This company |
| K110775 | 2011-05-13 | DXN | Traditional | This company |
| K131900 | 2014-03-05 | DPS | Traditional | Contec Medical System Co., Ltd. |
| K101273 | 2011-09-30 | MLO | Traditional | Contec Medical System Co., Ltd. |
| K110156 | 2011-07-27 | DXN | Traditional | Contec Medical System Co., Ltd. |
| K101692 | 2011-06-28 | MHX | Traditional | Contec Medical System Co., Ltd. |
| K110774 | 2011-05-13 | DXN | Traditional | Contec Medical System Co., Ltd. |
| K101127 | 2010-06-11 | MWI | Traditional | Contec Medical System Co., Ltd. |
| K090671 | 2009-06-11 | DQA | Traditional | Contec Medical System Co., Ltd. |
| K082480 | 2009-02-25 | KNG | Traditional | Contec Medical System Co., Ltd. |
| K082641 | 2008-11-10 | DQA | Special | Contec Medical System Co., Ltd. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-04-10 | Class II | Software design | Patient monitor has nine identified cybersecurity vulnerabilities. | 7773 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Employees | 1000 |
| Factory area | 67,450 |
| Main products | Pulse oximeter, Sphygmomanometer, ECG equipment, EEG equipment, Patient monitor |
| Certifications | ISO9001, ISO13485, ISO14001, BSCI |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | 17 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | 11 |
| Qinhuangdao Taizhi Medical Technology Co., Ltd. | 5 |
| Qinhuangdao Huisianpu Medical Systems Inc. | 4 |
| Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd. | 3 |
| Qinhuangdao Silide Ceramic Technology Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.