BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ContexGel.soft -6 mm-, without distal connection

    Reg #: 8010401 · FEI: 5812 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STREIFENEDER ortho.production gmbH
    Registration Number
    8010401
    FEI Number
    5812
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MOOSFELDSTRASSE 10
    City
    EMMERING Bavaria
    Country
    DE

    Owner / Operator

    Firm Name
    Streifeneder ortho.production GmbH
    Operator Number
    8010401
    Address
    MOOSFELDSTRASSE 10, --
    City
    EMMERING, BAVARIA
    State
    DE-BY
    Postal Code
    82275
    Country
    DE

    US Agent

    Business Name
    Fabtech Systems LLC.
    Contact Name
    Greg Mattson
    Address
    3304 Hill Avenue
    City
    Everett
    State
    WA
    ZIP
    98201
    Country
    US
    Email
    [email protected]
    Phone
    425 3499557

    Products

    Device Name Product Code
    Prosthesis, Thigh Socket, External Component ISS

    Proprietary Names

    ContexGel.soft -6 mm-, without distal connection DuoSil.basic, with distal connection ComfortSil.soft -6 mm-, without distal connection ContexGel.soft -6 mm-, with distal connection ClearSil.compression, Post surgical compression liner -Set 1- AK-Control.Sil -2 mm-, with distal connection, without silicone strip ComfortSil.soft -6 mm-, with distal connection ContexGel.protect, Protective cover for ContexGel.sleeve ContexGel.soft+ -9 mm-, with outer matrix, with distal connection ClearSil.basic, without distal connection ClearSil.compression, Post surgical compression liner Nylon Stocking ContexGel.soft -6 mm-, with outer matrix, with distal connection ContexGel.soft -6 mm-, with outer matrix, without distal connection ContexGel.soft+ -9 mm-, without distal connection ClearSil.basic, with distal connection ContexGel.basic -3 mm-, with outer matrix; without distal connection ClassicSil.basic -3 mm-, without distal connection ContexGel.protect AK-Control.Sil -2 mm-, with distal connection, with silicone strip ContexGel.basic -3 mm-, without distal connection ComfortSil.basic -3 mm-, with distal connection ContexGel.soft+ -9 mm-, with distal connection ComfortSil.basic -3 mm-, without distal connection ContexGel.soft+ -9 mm-, with outer matrix, without distal connection ContexGel.basic -3 mm-, with distal connection ClassicSil.soft -6 mm-, without distal connection ClassicSil.basic -3 mm-, with distal connection ClassicSil.soft -6 mm-, with distal connection ContexGel.basic -3 mm-, with outer matrix; with distal connection ContexGel.sleeve, Knee Sleeve Gel Liner; Silicone Liner; Above Knee & Below Knee Liner; Post surgical compression Liner; Gel Knee Sleeve Skin-Care Liner -3 mm- DAW-Slipper, donning aid for AK-prostheses Terrycloth BK-Stump Sock

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device