BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Halo Systems and accessories

    Reg #: 3003923579 · FEI: 3003923579 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLACK FOREST MEDICAL NORTH AMERICA, INC.
    Registration Number
    3003923579
    FEI Number
    3003923579
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4529 SE 16th Place, Suite 101
    City
    Cape Coral
    State
    FL
    ZIP
    33904
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063494

    Owner / Operator

    Firm Name
    pro med instruments GmbH
    Operator Number
    9041863
    Address
    BOETZINGER STRASSE 86, --
    City
    FREIBURG
    State
    Baden-Wurttemberg
    Postal Code
    79111
    Country
    DE

    Products

    Device Name Product Code
    Holder, Head, Neurosurgical (Skull Clamp) HBL

    Proprietary Names

    Halo Systems and accessories DORO® Radiolucent/MRI Compatible Cranial Stabilization and DORO® Skull Clamp RDL DORO® Horseshoe DORO®

    Establishment Types

    Manufacture Medical Device