BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Homostasis Valve

    Reg #: 3007138831 · FEI: 3007138831 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ALLWELL MEDICAL CORPORATION
    Registration Number
    3007138831
    FEI Number
    3007138831
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7424 Chapel Hill Rd 204
    City
    Raleigh
    State
    NC
    ZIP
    27607
    Country
    US

    Regulatory Submissions

    510(k) Number
    K925419

    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
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL

    Proprietary Names

    Homostasis Valve Angioplasty Pack Stockcocks

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device