FDA Registration
Active
🇨🇳 China
CONTEC MEDICAL SYSTEMS CO., LTD
Reg #: 3006979678
·
FEI: 3006979678
·
Expires 2026
Products
22
Proprietary Names
54
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- CONTEC MEDICAL SYSTEMS CO., LTD
- Registration Number
- 3006979678
- FEI Number
- 3006979678
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.112 Qinhuang West Street, Economic and Technical Development Zone
- City
- Qinhuangdao Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K110774
Owner / Operator
- Firm Name
- CONTEC MEDICAL SYSTEMS CO., LTD
- Operator Number
- 10025156
- Address
- No.112 Qinhuang West Street, Economic and Technical Development Zone
- City
- Qinhuangdao
- State
- Hebei
- Postal Code
- 066004
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2011-05-30 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2016-06-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-05-06 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-05-06 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2010-06-16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-05-06 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2015-03-25 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2022-10-18 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2025-08-08 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2015-09-15 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2014-11-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2009-06-29 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2011-11-16 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2021-07-25 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2011-06-30 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2011-06-30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2011-06-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2011-06-30 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2011-06-30 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2011-06-30 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2011-06-30 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2011-06-30 |
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
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
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
ABPM50 Automatic Blood Pressure Monitor
CONTEC10D Pocket Fetal Doppler
ECG90A Electrocardiograph
TP600 Infrared Thermometer
Sonoline B Pocket Fetal Doppler
Baby Sound C Pocket Fetal Doppler
Sonoline A Pocket Fetal Doppler
Baby Sound A Pocket Fetal Doppler
Baby Sound B Pocket Fetal Doppler
2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;
ECG1200G Electrocardiograph
ECG100G Electrocardiograph
ECG300G Electrocardiograph
CMS50DA Pulse Oximeter
Establishment Types
Manufacture Medical Device