FDA Registration
Active
🇰🇷 South Korea
TOPA12 Portable X-ray Unit
Reg #: 3021006193
·
FEI: 3021006193
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEUF Inc.
- Registration Number
- 3021006193
- FEI Number
- 3021006193
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon
- City
- Suncheon-si Jeonnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K230581
Owner / Operator
- Firm Name
- NEUF Inc.
- Operator Number
- 10083419
- Address
- #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon
- City
- Suncheon-si
- State
- Jeonnam
- Postal Code
- 58034
- Country
- KR
- Correspondent
- Woo Sang Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2023-08-27 |
Proprietary Names
TOPA12 Portable X-ray Unit
Establishment Types
Manufacture Medical Device