FDA Registration
Active
🇰🇷 South Korea
MSE-11
Reg #: 3005515228
·
FEI: 3005515228
·
Expires 2025
Products
1
Proprietary Names
45
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 |
|---|---|---|---|---|---|
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2005-12-15 |
Proprietary Names
MSE-11
MSE II-6 F
KBE II-6
MSE II-8 E
MSE-10
MSE II-10 F
MSE-12
MSE II-8 F
KBE II-10
KBE-8
KBE-6
MSE-6
MSE II-12 E
KBE II-8
MSE II-6 E
MSE II-12 F
MSE II-10 E
MSE-8
KBE II-12
MSE III-6 B
MSE II-10 H
MSE III-8 A
MSE II-6 G
MSE III-10 B
MSE II-8 G
MSE III-12 B
MSE IV-6 A
MSE II-10 G
MSE IV-8 B
MSE II-8 H
KBE-10
MSE III-6 A
MSE II-12 H
MSE IV-10 B
MSE II-6 H
MSE IV-12 A
MSE IV-6 B
KBE-12
MSE III-10 A
MSE III-12 A
MSE IV-8 A
MSE III-8 B
MSE IV-12 B
MSE IV-10 A
MSE II-12 G
Establishment Types
Manufacture Medical Device