FDA Registration
Active
🇰🇷 South Korea
KETOSCAN
Reg #: 3014937935
·
FEI: 3014937935
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SENTECH GMI Corp
- Registration Number
- 3014937935
- FEI Number
- 3014937935
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #1713~1714, 416, Hwagok-ro,, Gangseo-gu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Sentech Korea Corp
- Operator Number
- 9066277
- Address
- 21-6, Jimok-ro, 75beon-gil
- City
- Paju-Si
- State
- Gyeonggi
- Postal Code
- 10880
- Country
- KR
US Agent
- Business Name
- Kamm & Associates
- Contact Name
- Daniel Kamm
- Address
- 8870 Ravello Ct
- City
- Naples
- State
- FL
- ZIP
- 34114
- Country
- US
- [email protected]
- Phone
- 239 4171727
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Breath Measurement | NRH | Class 1 | Clinical Chemistry | No | 2018-10-18 |
Proprietary Names
KETOSCAN
KETOSCAN Mini
KETOSCAN Lite
KETOSCAN SMART
MultiGenix
Establishment Types
Manufacture Medical Device