FDA Registration
Active
🇨🇳 China
C50 and C80 Multi-parameter Patient Monitor
Reg #: 3008716327
·
FEI: 3008716327
·
Expires 2025
Products
22
Proprietary Names
1
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
- Registration Number
- 3008716327
- FEI Number
- 3008716327
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191106
Owner / Operator
- Firm Name
- Shenzhen Comen Medical Instruments Co., Ltd.
- Operator Number
- 10042479
- Address
- Floor10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- Gang Duan
US Agent
- Business Name
- Biologics Consulting
- Contact Name
- MARGARET VERNON
- Address
- 100 DAINGERFIELD ROAD, SUITE 400
- City
- Alexandria
- State
- VA
- ZIP
- 22314
- Country
- US
- [email protected]
- Phone
- 720 8833633
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-12-15 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-12-15 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2019-12-15 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2019-12-15 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2019-12-15 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2019-12-15 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2019-12-15 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2019-12-15 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2019-12-15 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-12-15 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2019-12-15 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2019-12-15 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-12-15 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2019-12-15 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2019-12-15 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2019-12-15 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2019-12-15 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2019-12-15 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2019-12-15 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2019-12-15 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2019-12-15 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2019-12-15 |
Proprietary Names
C50 and C80 Multi-parameter Patient Monitor
Establishment Types
Manufacture Medical Device