BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EcoBalloonDuo

    Reg #: 9611612 · FEI: 3002807847 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Registration Number
    9611612
    FEI Number
    3002807847
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KARL-HALL-STRASSE 01
    City
    GEISINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K090631

    Owner / Operator

    Firm Name
    PAJUNK GmbH Medizintechnologie
    Operator Number
    8010639
    Address
    Karl-Hall-Strasse 1
    City
    Geisingen
    State
    Baden-Wurttemberg
    Postal Code
    78187
    Country
    DE

    US Agent

    Business Name
    PAJUNK MEDICAL SYSTEMS
    Contact Name
    Marco Wohnig
    Address
    4575 Marconi Dr.
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    770 7572449

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    EcoBalloonDuo EcoBalloon DIL VarioBalloon URO EcoBalloon SB VarioBalloon SB VarioBalloon URO-S EcoBalloon RA VarioBalloon RA EcoBalloon DIL-BI MonoBalloon RA MonoBalloonDuo VarioBalloon RA-S EcoBalloonDuo DIL + SB EcoBalloon URO-S MonoBalloon SB MonoBalloon DIL-XL MonoBalloon URO EcoBalloonDuo DIL + RA MonoBalloon DIL EcoBalloon RA-S EcoBalloon DIL-XL MonoBalloon URO-S MonoBalloon RA-S MonoBalloon DIL-BI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device