FDA Registration
Active
🇰🇷 South Korea
ACCUNIQ BC300
Reg #: 9616164
·
FEI: 3001058906
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SELVAS Healthcare, Inc.
- Registration Number
- 9616164
- FEI Number
- 3001058906
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 155, Sinseong-ro
- City
- Yuseong-gu Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K092431
Owner / Operator
- Firm Name
- SELVAS Healthcare, Inc.
- Operator Number
- 9034171
- Address
- 155, Sinseong-ro, Yuseong-gu, Daejeon
- City
- Daejeon
- State
- KR-30
- Postal Code
- 34109
- Country
- KR
- Correspondent
- JiHyeon Yoon
US Agent
- Business Name
- HIMS, Inc.
- Contact Name
- Randy Ahn
- Address
- 2113 Wells Branch, Suite 6100,
- City
- Austin
- State
- TX
- ZIP
- 78728
- Country
- US
- [email protected]
- Phone
- 512 9609889
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2009-10-11 |
Proprietary Names
ACCUNIQ BC300
Establishment Types
Manufacture Medical Device