BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Impedimed SOZO

    Reg #: 3003695829 · FEI: 3003695829 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OnCore Manufacturing
    Registration Number
    3003695829
    FEI Number
    3003695829
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    125 Fisher Street
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180126

    Owner / Operator

    Firm Name
    OnCore Manufacturing LLC
    Operator Number
    10050743
    Address
    125 Fisher Street
    City
    Westborough
    State
    MA
    Postal Code
    01581
    Country
    US
    Correspondent
    John Marcil

    Products

    Device Name Product Code
    Monitor, Extracellular Fluid, Lymphedema, Extremity OBH

    Proprietary Names

    Impedimed SOZO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)