BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PregSense

    Reg #: 3016829704 · FEI: 3016829704 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nuvo Intl Group Inc.
    Registration Number
    3016829704
    FEI Number
    3016829704
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2980 NE 207TH ST.
    City
    Aventura
    State
    FL
    ZIP
    33180
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191401

    Owner / Operator

    Firm Name
    Nuvo Intl Group Inc
    Operator Number
    10071666
    Address
    2980 NE 207th St.
    City
    Aventura
    State
    FL
    Postal Code
    33180
    Country
    US
    Correspondent
    Adi Yarden

    Products

    Device Name Product Code
    Home Uterine Activity Monitor LQK

    Proprietary Names

    PregSense Invu

    Establishment Types

    Manufacture Medical Device