BEUDAMED
    FDA Registration Active 🇺🇸 United States

    One Step

    Reg #: 3021186226 · FEI: 3021186226 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HOME HEALTH US INCORPORATED
    Registration Number
    3021186226
    FEI Number
    3021186226
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7672 15th St E
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222472

    Owner / Operator

    Firm Name
    Home Health US Inc
    Operator Number
    10083434
    Address
    7672 15th Street E
    City
    Sarasota
    State
    FL
    Postal Code
    34243
    Country
    US
    Correspondent
    Luca J Hanson

    Products

    Device Name Product Code
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    One Step

    Establishment Types

    Repack or Relabel Medical Device