FDA Registration
Active
🇰🇷 South Korea
SO-0860-G2
Reg #: 3005515228
·
FEI: 3005515228
·
Expires 2025
Products
1
Proprietary Names
34
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMATERIALS KOREA INC.
- Registration Number
- 3005515228
- FEI Number
- 3005515228
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #413 #329 #331 150, Jojeong-daero
- City
- Hanam-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- BIOMATERIALS KOREA INC.
- Operator Number
- 9080640
- Address
- #413 #329 #331 150, Jojeong-daero
- City
- Hanam-si
- State
- Gyeonggi
- Postal Code
- 0
- Country
- KR
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2019-06-19 |
Proprietary Names
SO-0860-G2
SR-1438
SO-0860-G5
SO-2060
SR-4038-Z
SO-1860
SO-0860
MS saw(Right)-A
SR-4060
SO-1338
MS saw(Right)-S
SR-4060-D5
SR-4060-D6
S MS saw(Left)-S
SR-4060-Z
SR-4038
SR-4060-D4
SR-4060-D3
SO-1360
B0-3055
SR-3238
SO-1538
SR-4060-D2
SO-0860-G1
SR-2738
SR-4060-D7
SO-0860-G3
SP-3409
SO-1838
MS saw(Left)-A
SR-4038-AR
B0-5050
SO-0860-G4
SO-1560
Establishment Types
Manufacture Medical Device