BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NUMED, INC.

    Reg #: 1318694 · FEI: 1318694 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    34
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    NUMED, INC.
    Registration Number
    1318694
    FEI Number
    1318694
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2880 MAIN ST.
    City
    Hopkinton
    State
    NY
    ZIP
    12965
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041306
    PMA Number
    P150028

    Owner / Operator

    Firm Name
    NUMED, INC.
    Operator Number
    1318694
    Address
    2880 MAIN ST., --
    City
    Hopkinton
    State
    NY
    Postal Code
    12965
    Country
    US
    Correspondent
    NICHELLE R LAFLESH

    Products

    Device Name Product Code
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Percutaneous DQY
    Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon NVM
    Catheter, Intravascular, Diagnostic DQO
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ
    Introducer, Catheter DYB
    Aortic Stent PNF
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Balloon Aortic Valvuloplasty OZT
    Catheter, Septostomy DXF
    Catheter, Percutaneous (Valvuloplasty) MAD
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV

    Proprietary Names

    PTS-X Tyshak II & Z-MED II BIB Stent Placement Catheter NuCLEUS-X Multi-Track X-line Catheters COEfficient D'Vill Covered Mounted CP Stent CP Stent Mounted CP Stent Covered CP Stent NuDEL G-Armor Stent G-Armor Mounted Stent G-Armor Covered Mounted Stent G-Armor Covered Stent Ghost, Tyshak & Z-MED Z-MED II Z-MED PTS Tyshak & Z-MED Z-6 Atrioseptostomy Catheter Bonhoeffer Mitral Valve Kit NuCLEUS Ensemble™ II Transcatheter Valve Delivery System MINI GHOST CATHETER BIB Atrioseptostomy BIB CATHETER Mullins-X REBOA Tyshak Mini Tyshak NuCLEUS

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)