BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Siemens Healthineers Ltd.

    Reg #: 3002619337 · FEI: 3002619337 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Siemens Healthineers Ltd.
    Registration Number
    3002619337
    FEI Number
    3002619337
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 & 7 FI., Bundang First Tower, 55, Bundang-ro, Bundang-gu
    City
    SEONGNAM-SI Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230207

    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
    Biopsy Needle Guide Kit OIJ
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Catheter, Ultrasound, Intravascular OBJ
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON Redwood Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System ACUSON NX3 Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System ACUSON P500 Ultrasound System ACUSON P500 ICE Ultrasound System ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System ACUSON P500 Diagnostic Ultrasound System ACUSON Redwood Diagnostic Ultrasound System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility