Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002653540

FEI Number

3002653540

Entity Name

KOTEX DEVELOPMENT HOLIDINGS LTD

City/State/Country

KOWLOON, HONG KONG, CN

Establishment Address

Flat C, 3F Fully Ind. Bldg, 6 Tsun Yip Lane, Kwun Tong, KOWLOON, HONG KONG --, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

KOTEX DEVELOPMENT HOLDINGS LTD (Owner Number: 9068335)

Owner / Operator Contact Address

Flat C, 3F Fully Ind. Bldg.,, 6 Tsun Yip Lane, Kwun Tong, Kowloon, Kwun Tong, Kowloon, HK-NOTA 852, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043188

PMA Number

N/A

All Registered Proprietary Names

ALCOHAWK MICRO ALCOHAWK PRECISION ALCOHAWK SLIM ALCOHAWAK ELITE ALCOHAWK SLIM2 ALCOHAWK SLIM ULTRA

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	2004-11-17

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

KOTEX DEVELOPMENT HOLDINGS LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004848020	SUNTON ELECTRONICS CO., LTD.	Heyuan City Guangdong, CN

Similar Registrations

Registration Number	Establishment Name	Location
3002956991	PAS SYSTEMS INTERNATIONAL INC	Durham, NC, US
3007343307	DA TECH CO LTD	Incheon, KR
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002653540. Last updated year: 2026. Please use registration number 3002653540 when referencing this establishment in official correspondence.