FDA Registration
Active
🇨🇳 China
BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C)
Reg #: 3009156722
·
FEI: 3009156722
·
Expires 2025
Products
31
Proprietary Names
10
Establishment Types
1
Classifications
31
Registration Details
- Registration Name
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
- Registration Number
- 3009156722
- FEI Number
- 3009156722
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1203 Nanhuan Avenue, Guangming District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213799
Owner / Operator
- Firm Name
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
- Operator Number
- 9058402
- Address
- MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK
- City
- NANSHAN, SHENZHEN, GUANGDONG
- State
- CN-GD
- Postal Code
- 518057
- Country
- CN
US Agent
- Business Name
- Mindray DS USA, Inc
- Contact Name
- James Clifford
- Address
- 800 MacArthur Blvd
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
- [email protected]
- Phone
- 201 6709353
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2022-07-21 |
| Tester, Electrode, Surface, Electrocardiographic | KRC | Class 2 | Cardiovascular | No | 2022-07-21 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2022-07-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-07-21 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2022-07-21 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-07-21 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-07-21 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-07-21 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2022-07-21 |
| Monitor, St Segment | MLC | Class 2 | Cardiovascular | No | 2022-07-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-07-21 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2022-07-21 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2022-07-21 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2022-07-21 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-07-21 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2022-07-21 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-07-21 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-07-21 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-07-21 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2022-07-21 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-07-21 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-07-21 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2022-07-21 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-07-21 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-07-21 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2022-07-21 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2022-07-21 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-07-21 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2022-07-21 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-07-21 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-07-21 |
Proprietary Names
BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C)
BeneVision N Series Patient Monitors (Including BeneVision N19 ICU,BeneVision M22 ,BeneVision M22C)
BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU)
BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17)
BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo)
BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C)
BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo)
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17)
BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1)
BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo)
Establishment Types
Manufacture Medical Device