FDA Registration
Active
🇰🇷 South Korea
AR_N Fixture Driver for Wrench
Reg #: 3009611645
·
FEI: 3009611645
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOTEM CO., LTD.
- Registration Number
- 3009611645
- FEI Number
- 3009611645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- # 422, Sasang-ro, Sasang-gu
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- Biotem Co., Ltd.
- Operator Number
- 10057313
- Address
- # 422, Sasang-ro, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46925
- Country
- KR
US Agent
- Business Name
- GS GLOBAL USA, INC
- Contact Name
- Seong han Chung
- Address
- 17785 Center Court Dr., Suite 260
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
- [email protected]
- Phone
- 562 7773106
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2018-03-19 |
Proprietary Names
AR_N Fixture Driver for Wrench
BR Fixture Driver for Wrench
AR_N Fixture Driver for Machine
IR Fixture Driver for Machine
IR Fixture Driver for Wrench
BR Fixture Driver for Machine
Fixture Driver for Wrench
Fixture Driver for Machine
Establishment Types
Manufacture Medical Device