BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    Zimmon biliary stent

    Reg #: 3006891655 · FEI: 3006891655 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Seisa Europe s.r.o.
    Registration Number
    3006891655
    FEI Number
    3006891655
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    priemyselna 4
    City
    myjava Trenciansky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K040151

    Owner / Operator

    Firm Name
    Seisa Europe s.r.o.
    Operator Number
    10024045
    Address
    priemyselna 4
    City
    Myjava
    State
    Trenciansky
    Postal Code
    90701
    Country
    SK
    Correspondent
    Miroslava Janechova

    US Agent

    Business Name
    Tekni-Plex Healthcare
    Contact Name
    Jason Skramsted
    Address
    8721 US Hwy 70 West
    City
    Clayton
    State
    NC
    ZIP
    27520
    Country
    US
    Email
    [email protected]
    Phone
    984 9897708

    Products

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

    Proprietary Names

    Zimmon biliary stent

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)