FDA Registration
Active
🇰🇷 South Korea
iSOBER70
Reg #: 3003383868
·
FEI: 3003383868
·
Expires 2025
Products
1
Proprietary Names
57
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
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 | 2018-06-27 |
Proprietary Names
iSOBER70
iSOBER50
iSOBER200
iSOBER400
iSOBER90
ALCOSCAN AL2500Elite
ALCOSCAN AL8000
iSOBER70Pro
iSOBER S
ALCOSCAN AL5500
ALCOSCAN ALP-1 Lite
ALCOSCAN AL3100
iSOBER 50
ALCOSCAN AL9000
iSOBER 200
iSOBER30
ALCOSCAN AL6000
iblow 10
iSOBER10
ALCOSCAN AL6000Lite
ALCOSCAN AL1100F
ALCOSCAN AL4000
iSOBER 10
ALCOSCAN AL9010
ALCOSCAN AL2500
iblow 20
ALCOSCAN AL8800BT
ALCOSCAN ALP-1
ALCOSCAN AL3200
iSOBER 30
ALCOSCAN EBS-010
iSOBER 90
ALCOSCAN ALC-2
ALCOSCAN AL8800
ALCOSCAN AL1100
ALCOSCAN ADBs
iSOBER nano
ALCOSCAN AL9000Lite
iSOBER 400
ALCOSCAN AL7010
ALCOSCAN AL7000
ALCOSCAN ALC-1
ALCOSCAN EBS
iSOBER 70
iblow 10C
iSOBER 5
ALCOSCAN
AL8000Plus
ACE XS
Alcoscan AL8500
ACE XS Lite
iSOBER S Pro
ALCOSCAN Ki
iBLOW100
ALCOSCAN Ki Lite
ALX3000
iBLOW10 Pro
Establishment Types
Manufacture Medical Device