BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Black Forest Medical GmbH

    Reg #: 3003923584 · FEI: 3003923584 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Black Forest Medical GmbH
    Registration Number
    3003923584
    FEI Number
    3003923584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BOETZINGER STRASSE 86
    City
    FREIBURG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032331

    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

    US Agent

    Business Name
    BLACK FOREST MEDICAL NORTH AMERICA, INC.
    Contact Name
    MATTHIAS SCHUELE
    Address
    4529 Se 16th Pl Ste 101
    City
    Cape Coral
    State
    FL
    ZIP
    33904
    Country
    US
    Email
    [email protected]
    Phone
    239 3692310

    Products

    Device Name Product Code
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Headrest, Neurosurgical HBM
    Instrument, Surgical, Non-Powered HAO
    Table, Operating-Room, Mechanical FWX
    Tray, Surgical, Instrument FSM
    Table, Surgical With Orthopedic Accessories, Ac-Powered JEA

    Proprietary Names

    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 Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) DORO HEADREST DORO® Blade DORO QR3 XTom Headholder System DORO® Lubricant HP500, Six-pack DORO® Lubricant HP500 DORO Sterilization Tray DORO® LUCENT iMRI Interface Adaptor IMRIS DORO LUCENT® Skull Clamp Pediatric Set DORO LUCENT® Skull Clamp DORO QR3 Headrest System (Aluminum) DORO LUCENT® iXI and iMRI Headrest System DORO® LUCENT iMRI Coil Connector IMRIS Halo Systems and accessories Cranial Stabilization and DORO® Radiolucent/MRI Compatible DORO® Horseshoe DORO® Skull Clamp RDL

    Establishment Types

    Manufacture Medical Device