BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENESEE BIOMEDICAL, INC.

    Reg #: 1723241 · FEI: 1000517719 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    33
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    GENESEE BIOMEDICAL, INC.
    Registration Number
    1723241
    FEI Number
    1000517719
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    700 W Mississippi Ave Unit D5
    City
    DENVER
    State
    CO
    ZIP
    80223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K901531

    Owner / Operator

    Firm Name
    GENESEE BIOMEDICAL, INC.
    Operator Number
    9012312
    Address
    700 W Mississippi Ave, Unit D-5
    City
    Denver
    State
    CO
    Postal Code
    80223
    Country
    US
    Correspondent
    James Cross

    Products

    Device Name Product Code
    Thin Layer Chromatography, Ethosuximide DNP
    Instruments, Surgical, Cardiovascular DWS
    Bottle, Collection, Vacuum KDQ
    Ring, Annuloplasty KRH
    Continuous Measurement Thermometer FLL
    Sizer, Heart-Valve, Prosthesis DTI
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Set, Administration, Intravascular FPA
    Accessories, Catheter KGZ
    Stabilizer, Heart MWS
    Retractor GAD
    Controller, Temperature, Cardiopulmonary Bypass DWC
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Reusable Coronary Probes Thoracic Port Knot Pusher Aortic Valve Repair Tool Kit Suction Tubes Robotic Stainless Steel Valve Sizer Suture Hook Robotic Tool Kit HEART-LIFT CARDIAC RETRACTION SLING GENESEE UNIVERSAL "Y" CONNECTOR NeoForm Annuloplasty Ring Myocardial Temperature Probe TransForm McCarthy Mitral Annuloplasty Ring Sizers TransForm McCarthy Mitral Annuloplasty Ring WellsForm Tricuspid Annuloplasty Band TruForm Sievers Annuloplasty Ring Intra-Art Coronary Artery Retraction Clip, 3mm or 5mm Anastomark Coronary Graft Marker SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) LIPO-PORT ANASTOSURE (TM) LOC NESS (R) ANNULOPLASTY RING SIZER Large Patient Curved Sternal Retractor Child Curved Sternal Retractor Adult Curved Sternal Retractor Pediatric Curved Sternal Retractor AVATR Adult Thoracic Retractor Neonatal Curved Sternal Retractor Minimally Invasive Thoracic Retractor Cardiac Insulator Cardiac Insulation Pads FlexForm Annuloplasty Ring & FlexForm Annuloplasty Band

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)