BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KORU MEDICAL SYSTEMS, INC.

    Reg #: 3024122953 · FEI: 3024122953 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    KORU MEDICAL SYSTEMS, INC.
    Registration Number
    3024122953
    FEI Number
    3024122953
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 Corporate Drive
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211206

    Owner / Operator

    Firm Name
    KORU Medical Systems, Inc.
    Operator Number
    1318360
    Address
    100 Corporate Dr
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    Christine Trefethen

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    Immunoglobulin G (Igg) Infusion System PKP

    Proprietary Names

    Freedom Infusion System FreedomEdge Infusion System

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility