FDA Registration
Active
🇰🇷 South Korea
LUC-12M
Reg #: 3010515789
·
FEI: 3010515789
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LUCEM CO., LTD.
- Registration Number
- 3010515789
- FEI Number
- 3010515789
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10-167, Cheomdangieop 5-ro, Sandong-myeon
- City
- Gumi-si Gyeongbuk
- Country
- KR
Owner / Operator
- Firm Name
- LUCEM Co., Ltd.
- Operator Number
- 10045131
- Address
- 10-167, Cheomdangieop 5-ro, Sandong-myeon,
- City
- Gumi-si
- State
- Gyeongbuk
- Postal Code
- 39166
- Country
- KR
- Correspondent
- Sung-Ho Jo
US Agent
- Business Name
- DRGEM USA INC
- Contact Name
- WON YOUNG CHOI
- Address
- 7018 NW 50TH TER
- City
- Gainesville
- State
- FL
- ZIP
- 32653
- Country
- US
- [email protected]
- Phone
- 201 3706672
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | Class 1 | Radiology | No | 2013-10-23 |
Proprietary Names
LUC-12M
LUC-11M
LUC-9M
LUC-8M
LUC-10M
LUC-14U
LUC-15U
DXT-14U
DXT-8M
H1080D
DXT-15U
DXT-11M
H1074D
H1076D
DXT-12M
DXT-10M
Establishment Types
Manufacture Medical Device