BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    OPRA Implant System

    Reg #: 3006151021 · FEI: 3006151021 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LASER NOVA AB
    Registration Number
    3006151021
    FEI Number
    3006151021
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Odenskogsvagen 1A
    City
    Ostersund Jamtland
    Country
    SE

    Regulatory Submissions

    PMA Number
    H080004

    Owner / Operator

    Firm Name
    Laser Nova AB
    Operator Number
    10058331
    Address
    Odenskogsvagen 1A
    City
    Östersund
    State
    Jamtland
    Postal Code
    831 48
    Country
    SE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees PJY

    Proprietary Names

    OPRA Implant System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)