BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    S11103 Pajunk Labeled Safersonic Single

    Reg #: 3008177921 · FEI: 3008177921 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SAFERSONIC MEDIZINPRODUKTE HANDELSGES.M.B.H
    Registration Number
    3008177921
    FEI Number
    3008177921
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hauptstrasse 16/2
    City
    Persenbeug Niederosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K092858

    Owner / Operator

    Firm Name
    SAFERSONIC Medizinprodukte Handelsges.m.b.H
    Operator Number
    10057303
    Address
    Hauptstrasse 16/2
    City
    Persenbeug
    State
    AT-NOTA
    Postal Code
    A-3680
    Country
    AT

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    S11103 Pajunk Labeled Safersonic Single S11104 Pajunk Labeled Safersonic Conti DAN-33812U Safersonic Conti Non Sterile DAN-33805U Safersonic Medium Non Sterile DAN-33812 Safersonic Conti DAN-33803 Safersonic Single DAN-33825 Safersonic Long DAN-33803U Safersonic Single Non Sterile DAN-33803NT Safersonic Single - No Tape DAN-33805 Safersonic Medium DAN-33825U Safersonic Long Non Sterile

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device