FDA Registration
Active
🇰🇷 South Korea
Mask Surgical, Easy Breath, Antimicrobial
Reg #: 3017608802
·
FEI: 3017608802
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KBBIO CO., LTD.
- Registration Number
- 3017608802
- FEI Number
- 3017608802
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 165 Sunhwan-ro, Jungwon-gu
- City
- Seongnam Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K101128
Owner / Operator
- Firm Name
- KBBIO Co., Ltd.
- Operator Number
- 10078362
- Address
- 165 Sunhwan-ro, Jungwon-gu
- City
- Seongnam
- State
- Gyeonggi
- Postal Code
- 13207
- Country
- KR
- Correspondent
- Seyeoul Park
US Agent
- Business Name
- YTS Global Inc
- Contact Name
- Won Lee
- Address
- 7406 Alban Station Ct., A108
- City
- Springfield
- State
- VA
- ZIP
- 22150
- Country
- US
- [email protected]
- Phone
- 703 3408178
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Mask With Antimicrobial/Antiviral Agent | OUK | Class 2 | General, Plastic Surgery | No | 2021-12-28 |
Proprietary Names
Mask Surgical, Easy Breath, Antimicrobial
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)