BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sure-flex Balloon Dilatation Cath.

    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
    K901424

    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
    Dilator, Esophageal KNQ

    Proprietary Names

    Sure-flex Balloon Dilatation Cath.

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device