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
Phone
239 4171727

Products

Device Name Product Code
Devices, Breath Trapping, Alcohol DJZ

Proprietary Names

AlcoMate Premium

Establishment Types

Manufacture Medical Device