BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    SAFERSONIC MEDIZINPRODUKTE HANDELSGES.M.B.H

    Reg #: 3008177921 · FEI: 3008177921 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    SAFERSONIC MEDIZINPRODUKTE HANDELSGES.M.B.H
    Registration Number
    3008177921
    FEI Number
    3008177921
    Status
    Active
    Expiry Year
    2026
    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
    Regional Anesthesia Kit OFV
    Transducer, Ultrasonic, Diagnostic ITX
    Media, Coupling, Ultrasound MUI

    Proprietary Names

    DAN-33805WG Safersonic Medium with Gel DAN-33825WG to Safersonic Long with Gel S11101 Pajunk Labeled Safersonic Single with Gel DAN-33512NWG Safersonic Conti Narrow with Gel DAN-33803WG Safersonic Single with Gel DAN-33505N-WG DAN-33812WG to Safersonic Conti with Gel DAN-33505NWG Safersonic Medium Narrow with Gel S11103 Pajunk Labeled Safersonic Conti with Gel S11103 Pajunk Labeled Safersonic Single S11104 Pajunk Labeled Safersonic Conti DAN-33812U Safersonic Conti Non Sterile DAN-33825 Safersonic Long DAN-33803NT Safersonic Single - No Tape DAN-33805U Safersonic Medium Non Sterile DAN-33803 Safersonic Single DAN-33805 Safersonic Medium DAN-33803U Safersonic Single Non Sterile DAN-33812 Safersonic Conti DAN-33825U Safersonic Long Non Sterile Safergel Sterile Ultrasound Gel

    Establishment Types

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