FDA Registration
Active
🇰🇷 South Korea
AlzWIN-MD-US-25
Reg #: 3033520545
·
FEI: 3033520545
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEVEN POINT ONE
- Registration Number
- 3033520545
- FEI Number
- 3033520545
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite #301, Seoul Bio Hyuksin Community Center, 18 Jongamro, Sungbukgu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Seven Point One
- Operator Number
- 10091685
- Address
- Suite #301, Seoul Bio Hyuksin Community Center, 18 Jongamro, Sungbukgu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 02796
- Country
- KR
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computerized Cognitive Assessment Aid, Exempt | PTY | Class 2 | Neurology | No | 2024-10-23 |
Proprietary Names
AlzWIN-MD-US-25
Establishment Types
Manufacture Medical Device