BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Safergel Sterile Ultrasound Gel

    Reg #: 3008751375 · FEI: 3008751375 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H.
    Registration Number
    3008751375
    FEI Number
    3008751375
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Salzbergstrasse 96
    City
    Absam Tirol
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K190591

    Owner / Operator

    Firm Name
    Pharmazeutische Fabrik Montavit Ges.m.b.H.
    Operator Number
    10056924
    Address
    Salzbergstrasse 96
    City
    Absam
    State
    Tirol
    Postal Code
    6067
    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)