BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Introducer Sheath

    Reg #: 3005987240 · FEI: 3005987240 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALLWIN MEDICAL DEVICES, INC.
    Registration Number
    3005987240
    FEI Number
    3005987240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3305 E. MIRALOMA AVENUE, SUITE 176
    City
    ANAHEIM
    State
    CA
    ZIP
    92806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220781

    Owner / Operator

    Firm Name
    ALLWIN MEDICAL DEVICES, INC.
    Operator Number
    9094082
    Address
    3305 E. Miraloma Ave, SUITE 176
    City
    Anaheim
    State
    CA
    Postal Code
    92806
    Country
    US
    Correspondent
    Digish D Mehta

    Products

    Device Name Product Code
    Catheter, Nephrostomy LJE
    Dilator, Catheter, Ureteral EZN

    Proprietary Names

    Introducer Sheath ARMADA Ureteral Dilator Set Glider Amplatz Sheath ARMADA Nottingham One Step Dilator ARMADA Renal Dilator ARMADA Amplatz Renal Dilator Set Introducer Catheter Fascial Dilator

    Establishment Types

    Manufacture Medical Device