BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    M5Sc-RS

    Reg #: 9610482 · FEI: 3002808457 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE VINGMED ULTRASOUND A/S
    Registration Number
    9610482
    FEI Number
    3002808457
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    STRANDPROMENADEN 45
    City
    HORTEN Vestfold
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K221147

    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    M5Sc-RS E8Cs-RS 12L-RS 6S-RS 12S-RS 9T-RS 4C-RS C1-5-RS Vivid T9 E8C-RS 9L-RS Vivid T8 L8-18i-RS L6-12-RS Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG 8C-RS L4-20t-RS ML6-15-RS 6Tc-RS 3Sc-RS P2D

    Establishment Types

    Manufacture Medical Device