FDA Registration
Active
🇰🇷 South Korea
RFA-1717DI
Reg #: 3022131441
·
FEI: 3022131441
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASTEL.INC
- Registration Number
- 3022131441
- FEI Number
- 3022131441
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gajeongbuk-ro 26-79
- City
- Yuseong-gu Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K212051
Owner / Operator
- Firm Name
- ASTEL.Inc
- Operator Number
- 10084667
- Address
- Gajeongbuk-ro 26-79
- City
- Yuseong-gu
- State
- Daejeon
- Postal Code
- 34113
- Country
- KR
- Correspondent
- Yong Hwan Jeon
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St. Suite 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2022-03-20 |
Proprietary Names
RFA-1717DI
Establishment Types
Manufacture Medical Device