FDA Registration
Active
🇨🇳 China
BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer
Reg #: 3009156722
·
FEI: 3009156722
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
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
- K160370
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 |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2016-09-12 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2016-09-12 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2016-09-12 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2016-09-12 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2016-09-12 |
Proprietary Names
BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer
Establishment Types
Manufacture Medical Device