BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BLACK FOREST MEDICAL NORTH AMERICA, INC.

    Reg #: 3003923579 · FEI: 3003923579 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BLACK FOREST MEDICAL NORTH AMERICA, INC.
    Registration Number
    3003923579
    FEI Number
    3003923579
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4529 SE 16th Place, Suite 101
    City
    Cape Coral
    State
    FL
    ZIP
    33904
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191979

    Owner / Operator

    Firm Name
    Black Forest Medical 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
    Instrument, Surgical, Non-Powered HAO

    Proprietary Names

    DORO QR3 XTom Headholder System DORO® Blade DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Halo Systems and accessories Cranial Stabilization and DORO® Radiolucent/MRI Compatible DORO® Horseshoe DORO® Skull Clamp RDL DORO® DORO® Radiolucent Headrest System J-Arm Retractor System and Horseshoe Headrests DORO® Transitional Member Radiolucent DORO® Headrest System Radiolucent DORO® Base Unit Radiolucent DORO® Headrest System DORO® Skull Clamp DORO® Base Unit DORO® Swivel Adaptor DORO® Reusable Skull Pins DORO® QR3 Multipurpose Skull Clamp DORO LUCENT® iXI and iMRI Headrest System DORO® LUCENT iMRI Coil Connector IMRIS DORO QR3 Headrest System (Aluminum)

    Establishment Types

    Manufacture Medical Device