BEUDAMED
    FDA Registration Active 🇨🇳 China

    Breathalyzer AT8801

    Reg #: 3007037208 · FEI: 3007037208 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Hanwei Electronics Group Corporation
    Registration Number
    3007037208
    FEI Number
    3007037208
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.169, Xuesong Road, National Hi-Tech Zone
    City
    Zhengzhou Henan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K080848

    Owner / Operator

    Firm Name
    Hanwei Electronics Group
    Operator Number
    10033905
    Address
    No. 169 Xuesong Road, National Hi-Tech Zone
    City
    Zhengzhou
    State
    Henan
    Postal Code
    450001
    Country
    CN
    Correspondent
    Bob Sun

    US Agent

    Business Name
    KHN Solutions LLC
    Contact Name
    Keith Nothacker
    Address
    300 Broadway Ste 26
    City
    San Francisco
    State
    CA
    ZIP
    94133
    Country
    US
    Email
    [email protected]
    Phone
    415 6939756

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

    Breathalyzer AT8801 Breathalyzer AT8030 Breathalyzer AT8900 Breathalyzer AT7200 Breathalyzer AT800 Breathalyzer AT9000 Breathalyzer AT8800 Breathalyzer AT188 Breathalyzer AT7000 Breathalyzer AT8100 Breathalyzer AT7100 AlcoHAWK Breathalyzer AT319, AT319V, AT319S DT1000 Drug Tester AT7500 Rapid Screen Breathalyzer AT8901 Professional Breathalyzer AT202 Semiconductor Personal Breathalyzer Rapid Screen Breathalyzer AT7600 Breathalyzer AT809

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device