Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004848020

FEI Number

3004848020

Entity Name

SUNTON ELECTRONICS CO., LTD.

City/State/Country

Heyuan City Guangdong, CN

Establishment Address

2nd Floor, Building A, Baixin Science and Technology Park, Fuhe Industrial Transfer Park, Heping County, Heyuan City Guangdong --, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

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
3002653540	KOTEX DEVELOPMENT HOLIDINGS LTD	KOWLOON, HONG KONG, CN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004848020. Last updated year: 2026. Please use registration number 3004848020 when referencing this establishment in official correspondence.