Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007037208

FEI Number

3007037208

Entity Name

Hanwei Electronics Group Corporation

City/State/Country

Zhengzhou Henan, CN

Establishment Address

No.169, Xuesong Road, National Hi-Tech Zone, Zhengzhou Henan 450001, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hanwei Electronics Group (Owner Number: 10033905)

Owner / Operator Contact Address

No. 169 Xuesong Road, National Hi-Tech Zone, Zhengzhou, CN-HA 450001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Breathalyzer AT190 Breathalyzer AT800 Breathalyzer AT7200 Breathalyzer AT7000 Breathalyzer AT8800 AlcoHAWK Breathalyzer AT8100 Breathalyzer AT9000 Breathalyzer AT8900 Breathalyzer AT8801 Breathalyzer AT188 Breathalyzer AT7100 Breathalyzer AT8030 Breathalyzer AT319, AT319V, AT319S AT7500 Rapid Screen Breathalyzer DT1000 Drug Tester AT8901 Professional Breathalyzer Breathalyzer AT809 AT202 Semiconductor Personal Breathalyzer Breathalyzer AT805 Breathalyzer AT199 Breathalyzer AT7700 Breathalyzer AT329 Rapid Screen Breathalyzer AT7600 Breathalyzer AT9100 Breathalyzer AT7300 Alcohol Tester, Breathalyzer Breathalyzer AT808 Breathalyzer AT198 Breathalyzer AT8060 Breathalyzer AT800 Breathalyzer AT8020 Breathalyzer AT202 Breathalyzer AT602 Breathalyzer AT818 Breathalyzer AT8030 Breathalyzer AT218 Breathalyzer AT7300 Breathalyzer AT7000 Breathalyzer AT188

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	2010-10-18
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2018-08-21

Official Correspondent

Bob Sun

US Agent Details

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

Related Public Records

Same Entity

Hanwei Electronics Group

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 3007037208. Last updated year: 2026. Please use registration number 3007037208 when referencing this establishment in official correspondence.