BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Cardinal Health Mexico 244 S de RL de CV

    Reg #: 9616099 · FEI: 3003528016 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    53
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    Cardinal Health Mexico 244 S de RL de CV
    Registration Number
    9616099
    FEI Number
    3003528016
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Santiago Troncoso #808, PARQUE INDUSTRIAL SALVARCAR
    City
    Ciudad Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K914352
    PMA Number
    P030047

    Owner / Operator

    Firm Name
    Cordis US Corp.
    Operator Number
    1016427
    Address
    5452 Betsy Ross Drive, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Linda Ruedy

    US Agent

    Business Name
    Cordis US Corp.
    Contact Name
    Linda Ruedy
    Address
    5452 Betsy Ross Dr
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    408 8576754

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Catheter, Percutaneous DQY
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Intravascular, Diagnostic DQO
    Catheter For Crossing Total Occlusions PDU
    Filter, Intravascular, Cardiovascular DTK
    Device, Hemostasis, Vascular MGB
    Stent, Carotid NIM
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Cardiovascular Procedure Kit OEZ
    Set, Administration, Intravascular FPA
    Stent, Superficial Femoral Artery NIP
    Stent, Iliac NIO
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Cardiac Catheterization Kit OES

    Proprietary Names

    Vessel Dilator Vista Brite Tip Catheters RAIN Sheath™ Tibial Pedal Introducer AVANTI+ Catheter Sheath Introducer Trapease Permanent Vena Cava Filter Frontrunner OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Exoseal® Vascular Closure Device Brite Tip Catheter Enroute Transcarotid Stent System Vista Brite Tip Guiding Catheters Cordis EXOSEAL Vascular Closure Device S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System (modification) CORPAC - Cardiovascular Procedure Kit PROPAC Diagnostic Procedural System PRIMOPAC - Cardiovascular Procedure Kit Angiographic Catheter Extension PRECISE NITINOL STENT SYSTEM Smart Stent 5F SuperTorque Diagnostic Catheter Avanti Trans-radial sheath introducer kit CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR Modification to Smart Control S.M.A.R.T. RADIANZ Vascular Stent System S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System Brite Tip Sheath Introducer ADROIT Guiding Catheter 4F Tempo Aqua Diagnostic Catheter Envoy and Vista Brite Tip ( modification) S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System Preface Guiding Sheath Optease Vena Cava Filter RAILWAY™ Sheathless Access System Introducer Guide OPTEASE™ Retrievable Vena Cava Filter 4F Infiniti Diagnostic Catheter 4F & 5F Tempo Diagnostic Catheters 4F & 5F Nylex Diagnostic Catheters 5F Super Torque MB Diagnostic Catheter 7F & 8F High Flow Diagnostic Catheter INFINITI AMBI Diagnostic Catheter ANGIOGRAPHIC CATHETERIZATION SET 6F Super Torque Plus Diagnostic Catheter 4F Super Torque Diagnostic Catheter 5.2F Super Torque Plus Diagnostic Catheter 6F Super Torque Diagnostic Catheter Envoy & Vista Brite Tip 5F ADROIT Guiding Catheter 9F Envoy Guiding Catheter 5F & 6F Infiniti Diagnostic Catheter Brite Tip Catheter Sheath Introduce RAIN Sheath Transradial OUTBACK® Elite Re-Entry Catheter

    Establishment Types

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