BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STANDARD DIAGNOSTICS, INC.

    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
    K100398

    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
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    STANDARD DIAGNOSTICS, INC.

    Establishment Types

    Repack or Relabel Medical Device