BEUDAMED
    FDA Registration Active 🇫🇷 France

    Perouse Medical

    Reg #: 3006942524 · FEI: 3006942524 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    Perouse Medical
    Registration Number
    3006942524
    FEI Number
    3006942524
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Route du Manoir, Ivry-le-Temple
    City
    FRANCE Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K120261

    Owner / Operator

    Firm Name
    Perouse Medical
    Operator Number
    10024483
    Address
    Batiment LW1 1 Route des Troques
    City
    Chaponost
    State
    Auvergne-Rhone-Alpes
    Postal Code
    69630
    Country
    FR
    Correspondent
    Laura JULIEN

    US Agent

    Business Name
    VYGON USA
    Contact Name
    Chris Steinke
    Address
    2750 Morris Road Suite A200
    City
    Lansdale
    State
    PA
    ZIP
    19446
    Country
    US
    Email
    [email protected]
    Phone
    603 7435988

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Needle, Hypodermic, Single Lumen FMI
    Guide, Needle, Surgical GDF
    Syringe, Balloon Inflation MAV
    Orthopedic Manual Surgical Instrument LXH
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Port Introducer Kit OKE
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT

    Proprietary Names

    PPS PI® Pressure Injectable Safety Huber Needle STERILE NEEDLE GUIDE Dolphin Inflation Device POLYPERF POLYPERF Safe Inflation System MyShell Lite POLYSITE Implantable Infusion Port

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility