BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

    Reg #: 3021009035 · FEI: 3021009035 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nordson MEDICAL-Tecate
    Registration Number
    3021009035
    FEI Number
    3021009035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle los Olivos No. 6500, 1/D Modulo 3, Parque Industrial el Bajio
    City
    Tecate Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K180086

    Owner / Operator

    Firm Name
    Nordson MEDICAL
    Operator Number
    2244012
    Address
    1270 Eagan Industrial Road, Suite 200
    City
    Saint Paul
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Joel DeLaTorre

    US Agent

    Business Name
    Nordson Medical
    Contact Name
    Joel DeLaTorre
    Address
    1270 Eagan Industrial Rd Ste 120
    City
    Saint Paul
    State
    MN
    ZIP
    55121
    Country
    US
    Email
    [email protected]
    Phone
    507 4698373

    Products

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

    Proprietary Names

    Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)