Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003383868

FEI Number

3003383868

Entity Name

SENTECH KOREA CORP.

City/State/Country

PAJU-SI Gyeonggi, KR

Establishment Address

21-6, Jimok-ro 75beon-gil, PAJU-SI Gyeonggi 10880, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sentech Korea Corp (Owner Number: 9066277)

Owner / Operator Contact Address

21-6, Jimok-ro, 75beon-gil, Paju-Si, KR-41 10880, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AlcoMate Prestige AlcoScan AL6000 TX8800 ACE X ACE Easy AL7010 TX2500 Prime AL7000 TX8000 ALC-2 TX9010 AL8000 AL2500 Elite TX6010L TX9050L AL9000L AL6000L AL5500 AL8000NFC TX5500 TX9030 AL9010 ACE III Basic AL8800 TX7010 ACE II Basic AL2600 TX2600 TX8000NFC AL9000 TX20 ACE Neo ACE Soild TX2500 ALP-1 ALCOSCAN AL1100 AL1100 ACE Trusty AlcoMate SafeGuard AlcoScan AL2500 iSOBER10 iSOBER70 iSOBER30 ALCOSCAN AL7000 iSOBER400 iSOBER 10 iSOBER200 iSOBER70Pro iSOBER 90 iSOBER nano iSOBER90 ALCOSCAN AL9000 ALCOSCAN AL2500 ALCOSCAN AL8800BT iblow 10 ALCOSCAN AL8000 ALCOSCAN ALC-1 iblow 20 iSOBER50 iSOBER 70 ALCOSCAN AL1100 ALCOSCAN ADBs ALCOSCAN ALC-2 iSOBER S ALCOSCAN AL9010 ALCOSCAN AL6000 iSOBER 200 ALCOSCAN AL7010 ALCOSCAN ALP-1 Lite ALCOSCAN AL3100 ALCOSCAN AL8800 ALCOSCAN AL5500 ALCOSCAN AL6000Lite iSOBER 400 ALCOSCAN ALP-1 ALCOSCAN AL3200 ALCOSCAN AL1100F ALCOSCAN AL4000 ALCOSCAN AL9000Lite iSOBER 50 iSOBER 30 ALCOSCAN EBS ALCOSCAN AL2500Elite ALCOSCAN EBS-010 iblow 10C iSOBER 5 AL8000Plus ALCOSCAN iSOBER S Pro Alcoscan AL8500 ACE XS ALX3000 iBLOW100 ALCOSCAN Ki Lite ALCOSCAN Ki ACE XS Lite iBLOW10 Pro AlcoMate Premium MP1000 MP6000 MP-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2007-12-11
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2007-12-11
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2018-06-27
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2007-12-11
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2004-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

Sentech Korea Corp

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014937935	SENTECH GMI Corp	Seoul, KR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003383868. Last updated year: 2026. Please use registration number 3003383868 when referencing this establishment in official correspondence.