BEUDAMED
    FDA Registration Active 🇫🇷 France

    WESTLAKE PLASTICS EUROPE

    Reg #: 3011274144 · FEI: 3011274144 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    314
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    WESTLAKE PLASTICS EUROPE
    Registration Number
    3011274144
    FEI Number
    3011274144
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 rue de Maestricht
    City
    TOURCOING Nord
    Country
    FR

    Owner / Operator

    Firm Name
    WESTLAKE PLASTICS EUROPE
    Operator Number
    10048274
    Address
    2 rue de Maestricht
    City
    TOURCOING
    State
    Nord
    Postal Code
    59200
    Country
    FR

    US Agent

    Business Name
    Westlake Plastics Company
    Contact Name
    Yared Mengistu
    Address
    490 W. Lenni Road
    City
    Lenni
    State
    PA
    ZIP
    19052
    Country
    US
    Email
    [email protected]
    Phone
    610 4591000 ext. 2326

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Orthopedic Manual Surgical Instrument LXH
    Template HWT
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Transducer, Ultrasonic, Diagnostic ITX
    Reamer HTO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Elbow, Constrained, Cemented JDC
    Impactor HWA

    Proprietary Names

    PHYSICA KR KNEE SYSTEM SMR Hybrid Glenoid System MASTER SL FEMORAL STEM AGILON® XO retentive trial cap AGILON® XO inverse trial cap AGILON® XO trial glenosphere 32mm neutral AGILON® XO trial glenosphere 40mm eccentric AGILON® XO trial glenosphere 36mm eccentric AGILON® XO trial glenosphere 36mm neutral Tornier Perform® Humeral System Salto Talaris Total Ankle Prosthesis PB Uni PE impaction adapter Tornier Perform® Anatomic Glenoid Tornier Radial Head System Tornier Flex Shoulder System Aequalis® Reversed Fracture Aequalis® Reversed II Reunion Aequalis™ Instrument Orthopedic manual surgical instrument PB Uni tibial impaction clip TRAX CR Total Knee System - Instruments ACS® FB trial PE insert SC 4/13,75mm ACS® FB trial PE insert hyperflex 4/11,25mm ACS® FB trial PE insert ultra 2/13,75mm ACS® FB trial PE insert ultra 3/13,75mm ACS® FB trial PE insert hyperflex 6/12,5mm ACS® FB trial PE insert SC 3/11,25mm ACS® FB trial PE insert hyperflex 6/11,25mm ACS® FB trial PE insert hyperflex 2/11,25mm ACS® FB trial PE insert hyperflex 5/12,5mm ACS® FB trial PE insert hyperflex 2/13,75mm ACS® FB trial PE insert ultra 4 12,5mm MK trial femoral spacer distal rl/lm 4/10mm ACS® FB trial PE insert PS 2/10mm ACS® FB trial PE insert PS 2/12,5mm MK trial femoral spacer posterior 4/10mm MK trial femoral spacer posterior 5/5mm ACS® FB trial PE insert 3/11,25mm MK trial femoral spacer distal ll/rm 2,5/10mm ACS® FB tibial trial spacer ll/rm 3,5/5mm ACS® FB trial PE insert PS 5/10mm ACS® FB trial PE insert SC 5/10mm ACS® FB tibial trial spacer rl/lm 6/5mm ACS® FB trial PE insert PS 3/11,25mm MK trial femoral spacer distal ll/rm 5/5mm ACS® FB tibial trial spacer ll/rm 2/5mm ACS® FB trial PE insert PS 6/13,75mm ACS® FB tibial trial spacer ll/rm 2,5/10mm ACS® FB tibial trial adapter 4 17,5mm AGILON® XO trial glenoid sz. 4 ACS® FB tibial trial adapter 4 15mm ACS® FB tibial trial spacer rl/lm 3/5mm ACS® FB trial PE insert 4/13,75mm ACS® FB tibial trial spacer ll/rm 4/10mm ACS® FB tibial trial adapter 2 17,5mm MK trial femoral spacer distal rl/lm 2/10mm ACS® FB trial PE insert SC 3/10mm ACS® PE patella trial 26mm ACS® FB tibial trial spacer rl/lm 3,5/10mm ACS® FB trial PE insert PS 6/10mm ACS® FB tibial trial spacer rl/lm 4/10mm ACS® FB tibial trial spacer ll/rm 3/10mm ACS® FB trial PE insert PS 4/11,25mm MK trial femoral spacer posterior 2/5mm ACS® FB trial PE insert PS 6/12,5mm ACS® FB tibial trial adapter 2 15mm MK trial femoral spacer posterior 6/10mm ACS® FB tibial trial spacer rl/lm 5/5mm ACS® FB tibial trial spacer ll/rm 3/5mm ACS® FB trial PE insert PS 4/13,75mm ACS® FB trial PE insert hyperflex 3/10mm AGILON® XO trial glenoid sz. 2 MK trial femoral spacer distal ll/rm 2/5mm ACS® FB trial PE insert ultra 2/10mm ACS® FB tibial trial spacer ll/rm 6/5mm ACS® FB tibial trial adapter 6 15mm ACS® FB trial PE insert PS 3/10mm MK trial femoral spacer distal rl/lm 5/10mm ACS® FB tibial trial adapter 6 17,5mm MK trial femoral spacer posterior 3/10mm ACS® FB trial PE insert PS 6/11,25mm MK trial femoral spacer distal rl/lm 2,5/10mm ACS® FB trial PE insert SC 3/12,5mm ACS® FB tibial trial spacer rl/lm 2/5mm AGILON® XO trial glenoid sz. 3 ACS® FB trial PE insert hyperflex 5/10mm ACS® FB trial PE insert ultra 6 12,5mm ACS® FB trial PE insert hyperflex 4/12,5mm ACS® FB trial PE insert ultra 3 12,5mm MK trial femoral spacer distal rl/lm 2,5/5mm ACS® FB tibial trial spacer rl/lm 4/5mm MK trial femoral spacer posterior 2/10mm ACS® FB tibial trial adapter 2 20mm ACS® FB tibial trial spacer ll/rm 2/10mm ACS® FB trial PE insert 2/11,25mm ACS® FB tibial trial adapter 6 20mm MK trial femoral spacer distal ll/rm 5/10mm MK trial femoral spacer posterior 4/5mm MK trial femoral spacer distal rl/lm 4/5mm ACS® FB trial PE insert 2/13,75mm ACS® FB tibial trial spacer rl/lm 3/10mm ACS® FB trial PE insert ultra 3 10mm ACS® FB trial PE insert 5/13,75mm ACS® FB trial PE insert SC 2/11,25mm ACS® FB trial PE insert SC 2/13,75mm ACS® FB trial PE insert hyperflex 6/13,75mm ACS® FB trial PE insert SC 3/13,75mm ACS® FB trial PE insert SC 6/11,25mm MK trial femoral spacer posterior 2,5/5mm ACS® FB trial PE insert SC 6/12,5mm ACS® PE patella trial 35mm ACS® FB tibial trial adapter 5 20mm ACS® PE patella trial 29mm MK trial femoral spacer distal ll/rm 6/5mm ACS® FB tibial trial spacer rl/lm 2,5/10mm MK trial femoral spacer distal ll/rm 2/10mm ACS® FB trial PE insert ultra 2/11,25mm ACS® FB trial PE insert hyperflex 6/10mm ACS® FB trial PE insert ultra 5/11,25mm ACS® FB trial PE insert hyperflex 3/12,5mm ACS® FB trial PE insert hyperflex 5/13,75mm ACS® FB trial PE insert ultra 4/11,25mm ACS® FB trial PE insert ultra 5/13,75mm ACS® FB trial PE insert PS 2/13,75mm ACS® FB trial PE insert ultra 2 12,5mm MK trial femoral spacer distal ll/rm 3/10mm ACS® FB trial PE insert ultra 6/13,75mm ACS® FB tibial trial spacer rl/lm 2,5/5mm MK trial femoral spacer distal rl/lm 2/5mm ACS® FB trial PE insert SC 5/12,5mm ACS® FB trial PE insert PS 5/13,75mm ACS® FB tibial trial spacer ll/rm 3,5/10mm ACS® FB trial PE insert hyperflex 4/10mm ACS® FB trial PE insert hyperflex 4/13,75mm ACS® FB trial PE insert SC 4/12,5mm MK trial femoral spacer posterior 2,5/10mm ACS® FB trial PE insert ultra 6 10mm ACS® FB trial PE insert PS 3/12,5mm ACS® FB tibial trial spacer ll/rm 5/5mm ACS® FB trial PE insert 5/11,25mm ACS® FB tibial trial spacer rl/lm 6/10mm ACS® PE patella trial 32mm ACS® FB trial PE insert 3/13,75mm ACS® FB tibial trial adapter 4 20mm ACS® FB tibial trial adapter 5 15mm ACS® FB tibial trial spacer ll/rm 4/5mm MK trial femoral spacer distal rl/lm 5/5mm ACS® FB trial PE insert SC 4/10mm ACS® FB tibial trial spacer ll/rm 2,5/5mm ACS® FB trial PE insert 4/11,25mm ACS® FB tibial trial spacer ll/rm 5/10mm ACS® FB trial PE insert PS 2/11,25mm ACS® FB tibial trial adapter 5 17,5mm ACS® FB trial PE insert PS 3/13,75mm ACS® FB tibial trial spacer ll/rm 6/10mm ACS® FB tibial trial adapter 3 17,5mm AGILON® XO trial glenoid sz. 1 ACS® FB trial PE-insert hyperflex 5/11,25mm MK trial femoral spacer distal rl/lm 6/10mm ACS® FB trial PE insert PS 4/10mm ACS® FB trial PE insert ultra 5 10mm ACS® FB tibial trial spacer rl/lm 5/10mm MK trial femoral spacer distal ll/rm 4/10mm MK trial femoral spacer posterior 3/5mm MK trial femoral spacer distal ll/rm 6/10mm MK trial femoral spacer distal rl/lm 3/5mm ACS® FB tibial trial adapter 3 20mm ACS® FB trial PE insert PS 5/11,25mm ACS® FB tibial trial spacer rl/lm 3,5/5mm ACS® FB trial PE insert PS 4/12,5mm MK trial femoral spacer distal rl/lm 3/10mm ACS® FB trial PE insert SC 5/13,75mm MK trial femoral spacer distal ll/rm 2,5/5mm ACS® FB trial PE insert PS 5/12,5mm MK trial femoral spacer distal ll/rm 3/5mm ACS® FB trial PE insert 6/11,25mm MK trial femoral spacer distal rl/lm 6/5mm ACS® FB trial PE insert ultra 5 12,5mm ACS® FB tibial trial spacer rl/lm 2/10mm ACS® FB trial PE insert hyperflex 3/13,75mm MK trial femoral spacer posterior 5/10mm ACS® FB trial PE insert ultra 4 10mm MK trial femoral spacer distal ll/rm 4/5mm ACS® FB tibial trial adapter 3 15mm ACS® FB trial PE insert SC 6/10mm ACS® FB trial PE insert SC 2/12,5mm ACS® FB trial PE insert SC 2/10mm MK trial femoral spacer posterior 6/5mm ACS® FB trial PE insert 6/13,75mm ACS® FB trial PE insert SC 5/11,25mm ACS® FB trial PE insert ultra 6/11,25mm ACS® FB trial PE insert hyperflex 3/11,25mm ACS® FB trial PE insert SC 6/13,75mm ACS® FB trial PE insert ultra 4/13,75mm ACS® FB trial PE insert ultra 3/11,25mm ACS® FB trial PE insert SC 4/11,25mm Physica CR Knee System Uni FB tibial trial insert 0/9mm Uni FB PE-insert 1/8 mm Uni FB tibial insert 2/10mm Uni FB PE-insert 0/8mm Uni FB tibial insert 4/10mm Uni FB PE-insert 4/9 mm Uni FB tibial trial insert 1/14mm Uni FB tibial insert 3/10mm Uni FB tibial trial insert 0/10mm Uni FB PE-insert 4/11 mm Uni FB tibial trial insert 0/14mm Uni FB trial insert 2/8mm Uni FB PE-insert 4/14mm Uni FB PE-insert 0/11mm Uni FB tibial trial insert 0/8mm Uni FB PE-insert 2/12mm Uni FB tibial insert 3/11mm Uni FB PE-insert 4/8 mm Uni FB PE-insert 1/11 mm Uni FB PE-insert 2/11 mm Uni FB tibial trial insert 2/12mm Uni FB PE-insert 3/8 mm Uni FB PE-insert 3/12mm Uni FB PE-insert 1/14mm Uni FB PE-insert 3/14mm Uni FB tibial trial insert 4/12mm Uni FB tibial trial insert 3/12mm Uni FB tibial trial insert 2/14mm Uni FB PE-insert 2/10 mm Uni FB PE-insert 1/10 mm Uni FB trial insert 1/9mm Uni FB tibial insert 1/10mm Uni FB PE-insert 1/12mm Uni FB PE-insert 4/10 mm Uni FB tibial insert 1/11mm Uni FB PE-insert 3/9 mm Uni FB PE-insert 2/9 mm Uni FB tibial insert 4/11mm Uni FB PE-insert 0/14mm Uni FB PE-insert 2/8 mm Uni FB trial insert 3/8mm Uni FB trial insert 1/8mm Uni FB tibial trial insert 0/11mm Uni FB trial insert 4/9mm Uni FB tibial trial insert 1/12mm Uni FB PE-insert 0/12mm Uni FB PE-insert 2/14mm Uni FB PE-insert 3/11 mm Uni FB tibial insert 2/11mm Uni FB tibial trial insert 4/14mm Uni FB PE-insert 0/9mm Uni FB tibial insert 2/9mm Uni FB trial insert 3/9mm Uni FB tibial trial insert 3/14mm Uni FB tibial trial insert 0/12mm Uni FB tibial trial 4/8mm Uni FB PE-insert 3/10 mm Uni FB PE-insert 4/12mm Uni FB PE-insert 0/10mm Uni FB PE-insert 1/9 mm SMR Stemless Anatomic SMR TT Metal Back Glenoid Bone Graft instruments bipolar head sizing shell trial head taper 12/14mm PRIMA TT Glenoid NAIL 14G PERINE GRID 14G LIN LEAD 14G or LIN LEAD 18G CON LEAD 14G or CON LEAD 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.2) NAIL 18G PERINE FULL GRID 14G PERINE NAIL 14G or PERINE NAIL 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY END FIRE PROBE (v3.2) PERINE FULL GRID 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.3) PERINE GRID 18G SMR Shoulder System trial insert 15° neutral 0mm 36/44mm trial insert 15° 4mm offset 36/44mm trial insert 0° 4mm offset 36/52mm trial insert 15° neutral 0mm 36/48mm trial insert 0° 4mm offset 36/44mm trial insert 15° 4mm offset 36/48mm trial insert 0° 4mm offset 32/39mm trial insert 15° 4mm offset 36/52mm trial insert 15° neutral 0mm 32/39m trial insert 0° 4mm offset 36/48mm trial insert 15° neutral 0mm 36/52mm trial insert 15° 4mm offset 32/39mm SMR 3-Pegs Glenoids Flex Shoulder System ACS® PE-patella cemented 29 mm ACS® spacer shim 11,25mm ACS® spacer shim 13,75mm MK spacer for femoral positioner 5mm ACS® PE-patella cemented 32 mm ACS® PE-patella cemented 35 mm ACS® PE-patella cemented 26 mm ACS® SC FB tibial offset alignment MK spacer for femoral positioner 10mm TRAX CR Total Knee System Delta Dual Mobility System AGILON® XO PE-glenoid cemented 2 AGILON® XO PE-glenoid cemented 3 AGILON® XO PE-glenoid cemented 1 AGILON® XO PE-glenoid cemented 4 Delta TT Cups; Delta Liners Delta TT Pro SMR 3-PEGS GLENOIDS TEMA Elbow System MADISON SMR 40MM GLENOSPHERE Modulus femoral stems; Modular heads; Lock Bipolar heads; Cemented cups impactor for cup insert 36mm impactor for cup insert 32mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)