BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PharmaSmart International, LLC

    Reg #: 3007621003 · FEI: 3007621003 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    PharmaSmart International, LLC
    Registration Number
    3007621003
    FEI Number
    3007621003
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    125 Indigo Creek Drive, Suite 10
    City
    Rochester
    State
    NY
    ZIP
    14626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K811148

    Owner / Operator

    Firm Name
    PharmaSmart International, LLC
    Operator Number
    10029255
    Address
    125 Indigo Creek Drive, Suite 10
    City
    Rochester
    State
    NY
    Postal Code
    14626
    Country
    US
    Correspondent
    Fred Sarkis

    Products

    Device Name Product Code
    Computer, Blood-Pressure DSK
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    PS-1000LED Blood Pressure Monitor PS-1500 Blood Pressure Monitor PS-2000 Blood Pressure Monitor PS-1000 Blood Pressure Monitor

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility