BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALLWELL MEDICAL CORPORATION

    Reg #: 3007138831 · FEI: 3007138831 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    11
    Establishment Types
    4
    Classifications
    9

    Registration Details

    Registration Name
    ALLWELL MEDICAL CORPORATION
    Registration Number
    3007138831
    FEI Number
    3007138831
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7424 Chapel Hill Rd 204
    City
    Raleigh
    State
    NC
    ZIP
    27607
    Country
    US

    Regulatory Submissions

    510(k) Number
    K884913

    Owner / Operator

    Firm Name
    Allwell Medical Corporation
    Operator Number
    10024817
    Address
    7424 Chapel Hill Rd 204
    City
    Raleigh
    State
    NC
    Postal Code
    27607
    Country
    US
    Correspondent
    Jeff Wang

    Products

    Device Name Product Code
    Angiography/Angioplasty Kit OEQ
    Injector And Syringe, Angiographic DXT
    Catheter, Intravascular, Diagnostic DQO
    Wire, Guide, Catheter DQX
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Tube, Feeding FPD
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Syringe, Balloon Inflation MAV
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Inflation Syringe Kit Inflation Device Presure Monitoring Tube Introducer (Guide Wire Insertion To Homostasis Valve Angioplasty Pack Stockcocks Allwell Nastrogastric Feeding Tube Manifolds Torque Device Coronary Control Syringe

    Establishment Types

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