FDA Registration
Active
🇨🇳 China
Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T)
Reg #: 3007603826
·
FEI: 3007603826
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
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
- K240684
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
Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T)
Diagnostic Ultrasound System(Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp)
Diagnostic Ultrasound System(Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,Resona IV)
Diagnostic Ultrasound System(Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility