FDA Registration
Active
🇰🇷 South Korea
VIVACE
Reg #: 3010226575
·
FEI: 3010226575
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ShenB Co Ltd
- Registration Number
- 3010226575
- FEI Number
- 3010226575
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SHENB Tower, 74, Achasan-ro,
- City
- Seongdong-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K193070
Owner / Operator
- Firm Name
- ShenB Co Ltd
- Operator Number
- 10051010
- Address
- SHENB Tower, 74, Achasan-ro,
- City
- Seongdong-gu
- State
- Seoul
- Postal Code
- 04782
- Country
- KR
- Correspondent
- Sun Young Kang
US Agent
- Business Name
- Hoy & Associates Regulatory Consulting LLC
- Contact Name
- Connie Hoy
- Address
- 1830 Bonnie Way, Sacramento, California 95825 USA.
- City
- Sacramento
- State
- CA
- ZIP
- 95825
- Country
- US
- [email protected]
- Phone
- 530 9084903
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-05-06 |
Proprietary Names
VIVACE
VYBE RF
Establishment Types
Manufacture Medical Device