BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FREUDENBERG MEDICAL, LLC

    Reg #: 1222140 · FEI: 1000121130 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    FREUDENBERG MEDICAL, LLC
    Registration Number
    1222140
    FEI Number
    1000121130
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2301 Centennial Blvd
    City
    Jeffersonville
    State
    IN
    ZIP
    47130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190628

    Owner / Operator

    Firm Name
    Freudenberg Medical, LLC
    Operator Number
    9000550
    Address
    2301 Centennial Blvd., --
    City
    Jeffersonville
    State
    IN
    Postal Code
    47130
    Country
    US
    Correspondent
    Acelio L Hernandez

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Biopsy Needle FCG
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Marker, Radiographic, Implantable NEU
    Transducer, Pressure, Catheter Tip DXO
    Catheter, Pressure Monitoring, Cardiac OBI

    Proprietary Names

    BNX Fine Needle Aspiration System Ultra Long RFA Focal Catheter 80 Beacon Fine Needle Fiducial System Esophageal TTS, 120 Rapid Exchange (RXi) System and Navvus Catheter 90 RFA Focal Catheter 80 14 FR Low Profile Dilator System RFA Cleaning Cap SharkCore Fine Needle Biopsy System FlexSeal Introducer Sheath with Hydrophilic Coating Navvus II Catheter 60 RFA Focal Catheter 80 RFA Self Sizing Balloon Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device