FDA Registration
Active
🇰🇷 South Korea
MPXA
Reg #: 3027160711
·
FEI: 3027160711
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDIPIXEL, INC.
- Registration Number
- 3027160711
- FEI Number
- 3027160711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3/F 22 Teheran-ro 108-gil
- City
- Gangnam-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222036
Owner / Operator
- Firm Name
- Medipixel, Inc.
- Operator Number
- 10087806
- Address
- 3/F 22 Teheran-ro 108-gil
- City
- Gangnam-gu
- State
- Seoul
- Postal Code
- 06174
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-04-12 |
Proprietary Names
MPXA
Medipixel XA
Establishment Types
Manufacture Medical Device