BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FloSure

    Reg #: 3005813597 · FEI: 3005813597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIMEX MEDIZINTECHNIK GMBH
    Registration Number
    3005813597
    FEI Number
    3005813597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Brueckstr. 30/1
    City
    Deisslingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K150459

    Owner / Operator

    Firm Name
    SIMEX MEDIZINTECHNIK GMBH
    Operator Number
    9086230
    Address
    Brueckstr. 30/1, --
    City
    DEISSLINGEN
    State
    DE-NOTA
    Postal Code
    78652
    Country
    DE

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    FloSure FloSure Ventilation Patch

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility