BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    LAKE REGION MEDICAL LIMITED

    Reg #: 9681477 · FEI: 3002807439 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    LAKE REGION MEDICAL LIMITED
    Registration Number
    9681477
    FEI Number
    3002807439
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BUTLERSLAND
    City
    NEW ROSS Wexford
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K073082

    Owner / Operator

    Firm Name
    Lake Region Medical
    Operator Number
    2126666
    Address
    340 Lake Hazeltine Drive, --
    City
    Chaska
    State
    MN
    Postal Code
    55318
    Country
    US

    US Agent

    Business Name
    Lake Region Medical
    Contact Name
    Charlene Grilletto
    Address
    101 E. Mill Street, Suite P, Quakertown
    City
    Quakertown
    State
    PA
    ZIP
    18951
    Country
    US
    Email
    [email protected]
    Phone
    267 4508860

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stylet For Catheter, Gastro-Urology EZB
    Stylet, Ureteral EYA
    Tubes, Gastrointestinal (And Accessories) KNT
    System, Balloon, Intra-Aortic And Control DSP
    Arthroscope HRX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Introducer, Catheter DYB
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Monitor, Patient Position, Light-Beam IWE
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Catheter, Percutaneous, Intraspinal, Short Term MAJ
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Catheter, Nephrostomy LJE
    Stent, Ureteral FAD
    Accessories, Catheter, G-U KNY
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Catheter, Ureteral, Gastro-Urology EYB
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    Precision Lead Blank K970376 K935198 Steerant™ Super Stiff Guidewire K080144 Predicate III K850829 K770977 Torque Device K935170

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)