FDA Registration
Active
🇰🇷 South Korea
AlcoMate Premium
Reg #: 3003383868
·
FEI: 3003383868
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SENTECH KOREA CORP.
- Registration Number
- 3003383868
- FEI Number
- 3003383868
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21-6, Jimok-ro 75beon-gil
- City
- PAJU-SI Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K061922
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 |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2007-12-11 |
Proprietary Names
AlcoMate Premium
Establishment Types
Manufacture Medical Device