BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUNTON ELECTRONICS CO., LTD.

    Reg #: 3004848020 · FEI: 3004848020 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    SUNTON ELECTRONICS CO., LTD.
    Registration Number
    3004848020
    FEI Number
    3004848020
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd Floor, Building A, Baixin Science and Technology Park, Fuhe Industrial Transfer Park, Heping County
    City
    Heyuan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K043188

    Owner / Operator

    Firm Name
    KOTEX DEVELOPMENT HOLDINGS LTD
    Operator Number
    9068335
    Address
    Flat C, 3F Fully Ind. Bldg.,, 6 Tsun Yip Lane, Kwun Tong, Kowloon
    City
    Kwun Tong, Kowloon
    State
    HK-NOTA
    Postal Code
    852
    Country
    HK

    US Agent

    Business Name
    KHN Solutions, LLC
    Contact Name
    Keith Nothacker
    Address
    200 Green Street, 2nd Floor
    City
    San Francisco
    State
    CA
    ZIP
    94111
    Country
    US
    Email
    [email protected]
    Phone
    415 6939756

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

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

    Establishment Types

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