FDA Registration
Active
🇸🇬 Singapore
iSR'obot Mona Lisa 2
Reg #: 3008548323
·
FEI: 3008548323
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Biobot Surgical Pte. Ltd.
- Registration Number
- 3008548323
- FEI Number
- 3008548323
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 79 Ayer Rajah Crescent, #04-05
- City
- Singapore South West
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K213411
Owner / Operator
- Firm Name
- Biobot Surgical Pte. Ltd.
- Operator Number
- 10046782
- Address
- 79 Ayer Rajah Crescent, #04-05
- City
- SINGAPORE
- State
- SG-NOTA
- Postal Code
- 139955
- Country
- SG
- Correspondent
- Yan Shin Lim
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- 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 |
|---|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2022-09-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-09-14 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-09-14 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-09-14 |
Proprietary Names
iSR'obot Mona Lisa 2
Establishment Types
Manufacture Medical Device