FDA Registration
Active
🇰🇷 South Korea
BT-410F
Reg #: 3006179052
·
FEI: 3006179052
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Bistos co., ltd.
- Registration Number
- 3006179052
- FEI Number
- 3006179052
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 522, Geumeo-ro, Pogok-eup,, Cheoin-gu,
- City
- Yongin-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Bistos Co., Ltd.
- Operator Number
- 10023402
- Address
- 7th Fl., A Bldg., Woolim Lions Valley, 5-cha, 302 Galmachi-ro, Jungwon-gu,
- City
- Seongnam
- State
- Gyeonggi
- Postal Code
- 13201
- Country
- KR
US Agent
- Business Name
- Bistos America
- Contact Name
- Daniel Lim
- Address
- 22941 Triton Way, Suite 242
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 6148745
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2021-03-21 |
Proprietary Names
BT-410F
EYESCOPE
BT-410A
Head-worn light
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device