BEUDAMED
    FDA Registration Active 🇨🇳 China

    1.5T Signa HDxt Mobile

    Reg #: 3010949642 · FEI: 3010949642 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Registration Number
    3010949642
    FEI Number
    3010949642
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 266 Jingsan Road, Tianjin Airport Economic Area
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K121676

    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
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    1.5T Signa HDxt Mobile 3T SIGNA HDxt Mobile 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 1.5T SIGNA HDXt SIGNA VIBRANT 3T SIGNA HDXt

    Establishment Types

    Manufacture Medical Device