BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SoundStar 3D 10F Diagnostic Ultrasound Catheter

    Reg #: 3006985147 · FEI: 3006985147 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthineers Ltd.
    Registration Number
    3006985147
    FEI Number
    3006985147
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2nd & 3rd Venture Building, Pohang Technopark, 394, Jigok-ro, Nam-gu
    City
    Pohang-si Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K070242

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    US Agent

    Business Name
    Siemens Medical Solutions USA, Inc.
    Contact Name
    Zhengbin Xu
    Address
    22010 SE 51 Street
    City
    Issaquah
    State
    WA
    ZIP
    98029
    Country
    US
    Email
    [email protected]
    Phone
    425 2418272

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    SoundStar 3D 10F Diagnostic Ultrasound Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)