FDA Registration
Active
🇸🇬 Singapore
Vent Cap
Reg #: 3038613058
·
FEI: 3038613058
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SG ENDOSCOPY PTE LTD
- Registration Number
- 3038613058
- FEI Number
- 3038613058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 77 Loyang Way
- City
- Singapore North East
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K243894
Owner / Operator
- Firm Name
- SG Endoscopy Pte Ltd
- Operator Number
- 10093585
- Address
- 77 Loyang Way
- City
- Singapore
- State
- North East
- Postal Code
- 508765
- Country
- SG
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David David
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2025-06-06 |
Proprietary Names
Vent Cap
Cleaning Brush, External
Manual Leak Tester
Cleaning Brush, Working Channel, Ureteroscope
Single Luer Stopcock (pack of 2)
F88 Flexible Ureteroscope, Reverse Deflection
F88 Flexible Ureteroscope, Standard Deflection
F88 Flexible Camera Control Unit (CCU)
Cleaning Brush, Luer Port
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device