BEUDAMED
    FDA Registration Active 🇮🇳 India

    1.5T HD Breast Array

    Reg #: 9613936 · FEI: 1000571342 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WIPRO GE HEALTHCARE PRIVATE LTD
    Registration Number
    9613936
    FEI Number
    1000571342
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK
    City
    WHITEFIELD, BANGALORE Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K041695

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    1.5T HD Breast Array liberty 9000 8-ch breast coil with disposable biopsy plate 1.5T 8Ch GEM Breast Coil Lateral Large Grid Biopsy Plate Medial Large Grid Breast Biopsy Plate 1.5T HD Flat GEM Table Breast Array

    Establishment Types

    Manufacture Medical Device