BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Brachumera Sport PFM

    Reg #: 8030476 · FEI: 1000601592 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LODE B.V.
    Registration Number
    8030476
    FEI Number
    1000601592
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZERNIKEPARK 16
    City
    GRONINGEN
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K060820

    Owner / Operator

    Firm Name
    LODE B.V.
    Operator Number
    9019791
    Address
    ZERNIKEPARK 16, --
    City
    GRONINGEN
    State
    NL-NOTA
    Postal Code
    9747 AN
    Country
    NL
    Correspondent
    Jan Reinder - Fransens

    US Agent

    Business Name
    ElectraMed Corporation
    Contact Name
    Dana Burger-Dipzinski
    Address
    G-5332 Hill 23 Dr.
    City
    Flint
    State
    MI
    ZIP
    48507
    Country
    US
    Email
    [email protected]
    Phone
    800 6784856 ext. 4104

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    Brachumera Sport PFM Excalibur Sport Valiant 2 cpet Corival rehab Angio cpet - with static wall mount Angio rehab fixation set Corival Recumbent rehab Angio cpet - single set Valiant 2 cpet XL Flow cpet Valiant 2 pediatric Flow rehab Valiant 2 rehab Angio imaging fixation set Valiant 2 rehab XL Katana sport Corival cpet Excalibur Sport PFM Angio imaging support ultrasound Valiant 2 sport XL Angio rehab - static wall fixation Corival Pediatric Angio imaging support radiology Valiant 2 sport Angio rehab Corival OEM Brachumera Sport Katana sport XL Corival Recumbent cpet Angio cpet - with automatic stand Valiant 2 OEM Angio cpet - with electrical adjustable wall mount Angio rehab electrical wall fix.

    Establishment Types

    Manufacture Medical Device