FDA Registration
Active
🇬🇧 United Kingdom
Senhance Surgical System
Reg #: 9681503
·
FEI: 3002807793
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SRA Developments Ltd
- Registration Number
- 9681503
- FEI Number
- 3002807793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bremridge House, Bremridge
- City
- Ashburton Devon
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K182421
Owner / Operator
- Firm Name
- SRA DEVELOPMENTS, LTD.
- Operator Number
- 9024343
- Address
- BREMRIDGE HOUSE, --
- City
- ASHBURTON, DEVON
- State
- GB-NOTA
- Postal Code
- TQ137JX
- Country
- GB
- Correspondent
- Phillipa - Frewin
US Agent
- Business Name
- Emergo Global Consulting LLC
- Contact Name
- Greg Swanson
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2019-02-13 |
Proprietary Names
Senhance Surgical System
Senhance Ultrasonic System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)