FDA Registration
Active
🇨🇳 China
Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System
Reg #: 3007603826
·
FEI: 3007603826
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
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
- K222928
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
Proprietary Names
Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System
Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S Diagnostic Ultrasound System
Resona R9W, Resona R7W, Nuewa R9W, Nuewa R7W Diagnostic Ultrasound System
Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S Diagnostic Ultrasound 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