BEUDAMED
    FDA Registration Active 🇨🇳 China

    KardiaMobile 6L

    Reg #: 3005269793 · FEI: 3005269793 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CHINA TURNKEY SOLUTIONS LOGISTICS (SHENZHEN) CO., LTD.
    Registration Number
    3005269793
    FEI Number
    3005269793
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Warehouse 1 1/F, Area B 3/F, Area A 4/F, Excellence Logistics Center Building, 18 Shihua Road, Fubao Community, Fubao Street, Futian District,
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K183319

    Owner / Operator

    Firm Name
    CHINA TURNKEY SOLUTIONS LOGISTICS (SHENZHEN) CO.,LTD.
    Operator Number
    9075624
    Address
    Warehouse 1 1/F, Area B 3/F, Area A 4/F, Excellence Logistics Center Building, 18 Shihua Road, Fubao Community, Fubao Street, Futian District,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518045
    Country
    CN
    Correspondent
    Jennifer - Fu

    US Agent

    Business Name
    PCH International
    Contact Name
    Ken Vold
    Address
    3376 Taper Ave
    City
    San Jose
    State
    CA
    ZIP
    95124
    Country
    US
    Email
    [email protected]
    Phone
    408 8358472 ext. 2

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph Software For Over-The-Counter Use QDA
    Electrocardiograph DPS

    Proprietary Names

    KardiaMobile 6L

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)