FDA Registration
Active
🇨🇳 China
A3 ANESTHESIA DELIVERY SYSTEM
Reg #: 3007603826
·
FEI: 3007603826
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
2
Classifications
9
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
- K123211
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 |
|---|---|---|---|---|---|
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2013-02-26 |
Proprietary Names
A3 ANESTHESIA DELIVERY SYSTEM
A5 ANESTHESIA DELIVERY SYSTEM
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility