FDA Registration
Active
🇨🇳 China
BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C)
Reg #: 3007603826
·
FEI: 3007603826
·
Expires 2025
Products
31
Proprietary Names
10
Establishment Types
2
Classifications
31
Registration Details
- Registration Name
- Shenzhen Mindray Bio-Medical Electronics Co.,LTD
- Registration Number
- 3007603826
- FEI Number
- 3007603826
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN
- 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
- Correspondent
- Xinbing Wang
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
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility