BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTEC LLC

    Reg #: 1932738 · FEI: 1000143606 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    MEDTEC LLC
    Registration Number
    1932738
    FEI Number
    1000143606
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1401 8TH ST. S.E.
    City
    Orange City
    State
    IA
    ZIP
    51041
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211001

    Owner / Operator

    Firm Name
    Medtec LLC
    Operator Number
    9033077
    Address
    1401 8TH ST., S.E., --
    City
    Orange City
    State
    IA
    Postal Code
    51041
    Country
    US
    Correspondent
    Alena - Newgren

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Accelerator, Linear, Medical IYE
    Couch, Radiation Therapy, Powered JAI
    Instrument, Quality-Assurance, Radiologic LHO
    Holder, Head, Radiographic IWY
    Marker, Skin FZZ
    Table, Radiographic, Stationary Top IXQ
    Phase-Changing Fiducial Marker For Radiation Therapy QUV
    Vaginal Hydrogel Packing System QXR
    Shield, Protective, Personnel KPY
    Phantom, Anthropomorphic, Radiographic IXG

    Proprietary Names

    C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner Qfix Radiotherapy Chair QA TOOL MED-TEC LASER POSITIONER Protura Redi Foam Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt Protura Couch Software 1.3 trUpoint Arch DSA Head Holder Qfix Headholder Neuro Head Holder Nurofit MED-TEC SHOULDER SUPPRESSION SYSTEM MRI Redifoam MRI Headrest MRI Vac-Loc Cushions MRI Loc-bar MRI Thermoplastic MRI Uniframe Baseplate MRI Accuform Cushions AccuTatt; Accu-Tatt; ISO Mark; Opti-Tatt AccuForm Cushion Proton Positioning and Immobilization Solutions Breast Board MR & Radiological Patient Positioning Devices Type-S Extension BioXmark Fiducial Markers Vac-Loc cushions BrachyGel Vaginal Hydrogel Packing System Hipfix Hip & Pelvic fixation system MRI Patient Positioning Devices Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask Carbon Fiber Conformal Couch Top MED-TEC THERMOPLASTIC SHIELD MEDTEC FLAT-FOAM MEDTEC SHIELDING ALLOY Posifix Head & Neck Posifix head inclination system Posifix pediatric , SEQUEL TG-51) MED-TEC PHANTOMS (DISCOVERY Bellyboard SBRT Accessories Breast Board & Accessories

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility