FDA Registration
Active
🇰🇷 South Korea
GXR-EC50
Reg #: 3006551157
·
FEI: 3006551157
·
Expires 2025
Products
1
Proprietary Names
20
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 |
|---|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2007-05-11 |
Proprietary Names
GXR-EC50
GXR-E40
GXR-EC40
GXR-E25
GXR-EC32
GXR-EC25
GXR-40
GXR-C40
GXR-52
MXR-35
GXR-U32
GXR-82
GXR-68
GXR-C52
GXR-32
GXR-C32
GXR-U40
GXR-E32
GXR-E20
GXR-EC20
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility