FDA Registration
Active
🇰🇷 South Korea
VATECH CO., LTD.
Reg #: 3004706313
·
FEI: 3004706313
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- VATECH CO., LTD.
- Registration Number
- 3004706313
- FEI Number
- 3004706313
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13, Samsung 1-ro, 2-gil
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K240040
Owner / Operator
- Firm Name
- VATECH CO., LTD.
- Operator Number
- 9065556
- Address
- 13, Samsung 1-ro 2-gil
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18449
- Country
- KR
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St Ste 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 |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-12-12 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2024-12-12 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2013-06-10 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2023-07-20 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2023-04-28 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2021-07-01 |
Proprietary Names
VistaPano S 2 (Model: VistaPano S)
VistaPano S Ceph 2 (Model: VistaPano S Ceph)
Green X 12 SE (Model : PHT-40CHS)
Green X 21 (Model : PHT-90CHO)
Green X 12 Plus / Green X Plus (Model: PHT-70CHS)
Establishment Types
Manufacture Medical Device