BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Safergel Sterile Ultrasound Gel

    Reg #: 3008177921 · FEI: 3008177921 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K190591

    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
    Media, Coupling, Ultrasound MUI

    Proprietary Names

    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