BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sureflex Biliary Balloon Dilatation

    Reg #: 1222168 · FEI: 1222168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TeleMed Systems
    Registration Number
    1222168
    FEI Number
    1222168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 KANE INDUSTRIAL DR.
    City
    HUDSON
    State
    MA
    ZIP
    01749
    Country
    US

    Regulatory Submissions

    510(k) Number
    K901432

    Owner / Operator

    Firm Name
    SHENT USA, INC.
    Operator Number
    10078923
    Address
    8 Kane Industrial Drive
    City
    Hudson
    State
    MA
    Postal Code
    01749
    Country
    US
    Correspondent
    Hanbin Suh

    Products

    Device Name Product Code
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    Sureflex Biliary Balloon Dilatation

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device