BEUDAMED
    FDA Registration Active 🇫🇷 France

    SIPA

    Reg #: 3002808466 · FEI: 3002808466 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    SIPA
    Registration Number
    3002808466
    FEI Number
    3002808466
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22 Avenue Stroh
    City
    Avesnes Sur Helpe Hauts-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K832628

    Owner / Operator

    Firm Name
    VYGON S A
    Operator Number
    8020785
    Address
    5-11 RUE ADELINE, --
    City
    ECOUEN
    State
    FR-NOTA
    Postal Code
    95440
    Country
    FR
    Correspondent
    Chris Steinke

    US Agent

    Business Name
    Vygon USA
    Contact Name
    Chris Steinke
    Address
    87 Venture Drive
    City
    Dover
    State
    NH
    ZIP
    03820
    Country
    US
    Email
    [email protected]
    Phone
    603 7435988 ext. 227

    Products

    Device Name Product Code
    Kit, Surgical Instrument, Disposable KDD
    Catheter, Umbilical Artery FOS
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter, Intravascular, Diagnostic DQO
    Stand, Infusion FOX
    Set, Administration, Intravascular FPA

    Proprietary Names

    Thoracic trocar and drain Vygon XRO PVC Venous/Arterial Umbilical Catheter Vyclic Vygon Spinal Anesthesia Needle w/ Introducer Boussignac Lectrocath Caps and Connectors Nutrisafe 2 Lectospiral

    Establishment Types

    Manufacture Medical Device