BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Aco Apache Ultrasound System (model: neo C62)

    Reg #: 3025786376 · FEI: 3025786376 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ACO HEALTHCARE CO., LTD.
    Registration Number
    3025786376
    FEI Number
    3025786376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F, No.8-1, Nandong Rd., Pingzhen Dist
    City
    Taoyuan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K231509

    Owner / Operator

    Firm Name
    Aco Healthcare Co., Ltd.
    Operator Number
    10089889
    Address
    1F, No.8-1, Nandong Rd., Pingzhen Dist
    City
    Taoyuan City
    State
    TW-TAO
    Postal Code
    324
    Country
    TW
    Correspondent
    Henry Huang

    US Agent

    Business Name
    MDSS USA LLC
    Contact Name
    Marissa Vilchez
    Address
    6118 W. Lawrence Avenue
    City
    Chicago
    State
    IL
    ZIP
    60630
    Country
    US
    Email
    [email protected]
    Phone
    312 9751694

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Aco Apache Ultrasound System (model: neo C62) neo Medical Ultrasound System (model: neo P42) Aco Apache Ultrasound System (model: L154) Aco Apache Ultrasound System (model: neo P3H) neo Medical Ultrasound System (model: neo C62) Aco Apache Ultrasound System (model: C62) neo Medical Ultrasound System (model: neo L154) Aco Apache Ultrasound System (model: neo P42) neo Medical Ultrasound System (model: neo L187) Aco Apache Ultrasound System (model: neo L154) Aco Apache Ultrasound System (model: neo L187)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device