BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Prodigy Pro

    Reg #: 9616047 · FEI: 3003377038 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.
    Registration Number
    9616047
    FEI Number
    3003377038
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA
    City
    APODACA Nuevo Leon
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K161682

    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
    Densitometer, Bone KGI

    Proprietary Names

    Prodigy Pro GE Lunar DXA Bone Densitometers with enCORE version 17 iDXA Prodigy Advance Prodigy Lunar iDXA Prodigy Primo Prodigy Primo Compact Prodigy Pro Compact

    Establishment Types

    Manufacture Medical Device