BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Femoral Epidrill

    Reg #: 9681739 · FEI: 3002806515 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIO-HOSPITAL AB
    Registration Number
    9681739
    FEI Number
    3002806515
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    63 VERKSTADSVAGEN
    City
    KOPPARBERG Orebro
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K221048

    Owner / Operator

    Firm Name
    BIO-HOSPITAL AB
    Operator Number
    9026858
    Address
    63 VERKSTADSVAGEN, --
    City
    KOPPARBERG
    State
    SE-NOTA
    Postal Code
    S-71430
    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
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    Femoral Epidrill Patellar Epidrill

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)