DA TECH CO LTD

FDA Device Registration & Listing · Incheon, KR · Registration 3007343307

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007343307
FEI Number
3007343307
Entity Name
DA TECH CO LTD
City/State/Country
Incheon, KR
Establishment Address
13, Seounsandan-ro 4-gil, Gyeyang-gu, Incheon 21072, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DA TECH CO LTD (Owner Number: 10027379)
Owner / Operator Contact Address
13, Seounsandan-ro 4-gil, Gyeyang-gu, Incheon, KR-28 21072, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090067
PMA Number
N/A

All Registered Proprietary Names

Bactrack Select S50 BACTRACK S30 BACTRACK S70 BACTRACK Element BACTRACK S82 BACTRACK S75 BACTRACK S80 BACTRACK S78

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 2008-10-31
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2011-09-05

Official Correspondent

No official correspondent registered.

US Agent Details

Keith Nothacker Business: KHN Solutions, LLC Email: fda@bactrack.com Phone: (415) 6939756

Related Public Records

Same Entity

DA TECH CO LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3002956991 PAS SYSTEMS INTERNATIONAL INC Durham, NC, US
3042276415 SHENZHEN MEIRUI SHANGPIN TECHNOLOGY CO., LTD. Shenzhen Guangdong, CN
3013585270 Consumer Safety Technology, LLC Urbandale, IA, US
3013019743 SOBERLINK HEALTHCARE LLC Huntington Beach, CA, US
2030633 JANT PHARMACAL CORP. ENCINO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007343307. Last updated year: 2026. Please use registration number 3007343307 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.