FDA Registration
Active
🇰🇷 South Korea
TS-FC6
Reg #: 3006551157
·
FEI: 3006551157
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRGEM CORPORATION
- Registration Number
- 3006551157
- FEI Number
- 3006551157
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro
- City
- Gwangmyeong-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- DRGEM CORPORATION
- Operator Number
- 9101499
- Address
- 7Fl, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro,
- City
- Gwangmyeong-si
- State
- Gyeonggi
- Postal Code
- 14322
- Country
- KR
US Agent
- Business Name
- DRGEM AMERICA INC
- Contact Name
- Alex Lee
- Address
- 13755 HUTTON DR, Suite 500
- City
- Farmers Branch
- State
- TX
- ZIP
- 75234
- Country
- US
- [email protected]
- Phone
- 469 6109068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube Mount, X-Ray, Diagnostic | IYB | Class 1 | Radiology | No | 2009-09-04 |
Proprietary Names
TS-FC6
TS-FC4
TS-CSA
TS-FM6
TS-FC2
TS-CSP
TS-CSE
TS-FT4
TS-FT6
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility