BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ASUS

    Reg #: 1000602763 · FEI: 1000602763 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ASUS
    Registration Number
    1000602763
    FEI Number
    1000602763
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1F, No. 15, Li-Te Rd., Beitou Dist.
    City
    Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K250791

    Owner / Operator

    Firm Name
    ASUS
    Operator Number
    10079657
    Address
    No. 15, Li-Te Rd., Beitou Dist.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    112
    Country
    TW
    Correspondent
    Yu-Ying Chen

    US Agent

    Business Name
    ASUS COMPUTER INTERNATIONAL
    Contact Name
    Jeff Wang
    Address
    48720 Kato Rd
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US
    Email
    [email protected]
    Phone
    510 3966073

    Products

    Device Name Product Code
    System, Digital Image Communications, Radiological LMD
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    MH3281A, MH3281A-W, MH3281AY, MH3281AZ, MH3281A-P, MH3281A-J, MH3281A-R, MH3281A-E, MH2441A, MH2441A-W, MH2441AY, MH2441AZ, MH2441A-P, MH2441A-J, MH2441A-R, MH2441A-E MH2741A, MH2741A-W, MH2741AY, MH2741AZ, MH2741A-P, MH2741A-J, MH2741A-R, MH2741A-E, ASUS Ultrasound Imaging System (Model: LU800 series)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility