FDA Registration
Active
🇰🇷 South Korea
HUDENS BIO CO., LTD.
Reg #: 3021666765
·
FEI: 3021666765
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HUDENS BIO CO., LTD.
- Registration Number
- 3021666765
- FEI Number
- 3021666765
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 318 Cheomdanyeonsin-ro, Buk-gu
- City
- Gwangju
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K251818
Owner / Operator
- Firm Name
- HUDENS BIO CO., LTD.
- Operator Number
- 10095544
- Address
- 318 Cheomdanyeonsin-ro, Buk-gu
- City
- Gwangju
- State
- KR-29
- Postal Code
- 61088
- Country
- KR
- Correspondent
- Hun Kim
US Agent
- Business Name
- K-Biotech Incorporated
- Contact Name
- Kyungyoon Kang
- Address
- 1820 Gateway Dr
- City
- San Mateo
- State
- CA
- ZIP
- 94404
- Country
- US
- [email protected]
- Phone
- 408 7507843
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2026-03-29 |
Proprietary Names
BONTREE PLUS
Establishment Types
Manufacture Medical Device