FDA Registration
Active
🇸🇬 Singapore
FONG'S ENGINEERING & MANUFACTURING PRIVATE LIMITED
Reg #: 3007303113
·
FEI: 3007303113
·
Expires 2026
Products
12
Proprietary Names
6
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- FONG'S ENGINEERING & MANUFACTURING PRIVATE LIMITED
- Registration Number
- 3007303113
- FEI Number
- 3007303113
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 79 Loyang Way, Site 2 address: 77 Loyang Way
- City
- Singapore Central Singapore
- Country
- SG
Owner / Operator
- Firm Name
- Fong's Engineering & Manufacturing Private Limited
- Operator Number
- 10027091
- Address
- 79 Loyang Way, 77 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 | 2017-12-13 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2025-09-05 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2022-01-03 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-01-03 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
| Light, Catheter, Fiberoptic, Glass, Ureteral | FCS | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-02-17 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-02-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-03-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-03-20 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2024-03-20 |
Proprietary Names
Senhance Surgical System
Senahnce Articulating Instrument Adapter
Senhance Articulating Instrument Coupler
ATTUNE KNEE SYSTEM REVISION FEMORAL TRIAL REAMER GUIDE SZ3 LEFT
ATTUNE KNEE SYSTEM TIBIAL DRILL PEG TOWER NON-CEMENTED SIZE 1
ATTUNE KNEE SYSTEM REVISION CONVENTIONAL CUT GUIDE SIZE 1
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)