Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014059993

FEI Number

3014059993

Entity Name

DONG GUAN EEK ELECTRONIC TECHNOLOGY CO.,LIMITED

City/State/Country

Dong guan Guangdong, CN

Establishment Address

Room 401, Building 2, No. 345, Zhangmutou Section, Dongshen Road, Zhangmutou Town, Dong guan Guangdong 523622, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

DONG GUAN EEK ELECTRONIC TECHNOLOGY CO.,LIMITED (Owner Number: 10056014)

Owner / Operator Contact Address

Room 401, Building 2, No. 345, Zhangmutou Section, Dongshen Road, Zhangmutou Town, Dong guan, CN-GD 523622, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blood Alcohol Tester Mouthpiece(30 pack); LCD alcohol tester, Devices, breath Trapping alcohol; Breath alcohol test systems Mouthepiece; breathing-accumed Blood Tester mouthpiece (10 pack) Alcohol Tester; breathalyzer; a breath-alcohol test system; Ketone Breath Meter; Odor Detector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-10-27
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2017-12-25

Official Correspondent

Yanzhao Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

DONG GUAN EEK ELECTRONIC TECHNOLOGY CO.,LIMITED

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014059993. Last updated year: 2026. Please use registration number 3014059993 when referencing this establishment in official correspondence.