FDA Registration
Active
🇸🇬 Singapore
Senhance Surgical System
Reg #: 3007303113
·
FEI: 3007303113
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FONG'S ENGINEERING & MANUFACTURING PRIVATE LIMITED
- Registration Number
- 3007303113
- FEI Number
- 3007303113
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 79 Loyang Way
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K181517
Owner / Operator
- Firm Name
- Fong's Engineering & Manufacturing Private Limited
- Operator Number
- 10027091
- Address
- 79 Loyang Way
- City
- Singapore
- State
- SG-NOTA
- Postal Code
- 508766
- Country
- SG
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2019-01-04 |
Proprietary Names
Senhance Surgical System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)