FDA Registration
Active
🇨🇳 China
BeneVision Central Monitoring System
Reg #: 3009156722
·
FEI: 3009156722
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K183238
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 |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2019-03-13 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2019-03-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-03-13 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-03-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-03-13 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2019-03-13 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2019-03-13 |
Proprietary Names
BeneVision Central Monitoring System
Establishment Types
Manufacture Medical Device