BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    MATERIALISE N.V.

    Reg #: 3003998208 · FEI: 3003998208 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    109
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    MATERIALISE N.V.
    Registration Number
    3003998208
    FEI Number
    3003998208
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15 TECHNOLOGIELAAN
    City
    LEUVEN Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K253793

    Owner / Operator

    Firm Name
    MATERIALISE N.V.
    Operator Number
    9029485
    Address
    Technologielaan 15, --
    City
    Leuven
    State
    BE-NOTA
    Postal Code
    3001
    Country
    BE

    US Agent

    Business Name
    Materialise USA
    Contact Name
    Jenny Jones
    Address
    44650 Helm Court
    City
    Plymouth
    State
    MI
    ZIP
    48170
    Country
    US
    Email
    [email protected]
    Phone
    734 2597017

    Products

    Device Name Product Code
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    System, Image Processing, Radiological LLZ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Plate, Bone JEY
    Shoulder Prosthesis, Reverse Configuration PHX
    Shoulder Arthroplasty Implantation System QHE
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Distometer HMM
    Medical Device Data System OUG
    Oral Airway Assist PHS
    Orthopaedic Surgical Planning And Instrument Guides PBF
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Driver, Wire, And Bone Drill, Manual DZJ
    Orthosis, Corrective Shoe KNP
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Template HWT
    Cranial Surgical Planning And Instrument Guides PPT
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    BKS Total PSI Signature Guides Materialise TKA Guide System Materialise TKA Guides and Models Zimmer Biomet Patient Specific Instruments Materialise TKA Guide Planner SurgiCase Knee Planner Materialise Knee Guide System Zimmer Patient Specific Instruments Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise Knee Planner Lima Personalized Surgical Instruments Materialise Knee Platform Signature Planner Mimics Viewer XR Viewer SurgiCase Viewer Mimics Enlight Materialise Mimics Enlight OrthoView SurgiCase Shoulder Planner Match Point System Materialise Glenoid Positioning System guides Materialise Shoulder Planner Match Point System guides Materialise SurgiCase Planner Materialise Glenoid Positioning System TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Titanium 3D Printed Implant System Materialise Shoulder System Materialise Shoulder Guide and Models AtlasPlan Shoulder System TruMatch Personalized Solutions Shoulder Guide SurgiCase Planner Mimics Cardiac Planner Signature Personalized Patient Care System Signature Guide Materialise PKA Guides Materialise PKA Guide planner Materialise Knee Guide planner Materialise PKA Guide System Materialise TKA Guide planner Materialise Eyewear Fitting Suite SurgiCase Online Management System Zimmer Patient Specific Instruments Online Management System SurgiCase Transfer SurgiCase OOS SurgiCase Online Signature Online Management System SurgiCase Drive SurgiCase Mobile ProPlan CMF Online Bespoke PSI Bespoke Patient Specific Instruments Zimmer Patient Specific Instruments System SurgiCase Connect SurgiCase Guide SurgiCase Orthopaedics SurgiCase System SurgiCase TruMatch Personalized Solutions Shoulder System Mimics Thoracic Planner Mimics Medical Mimics inPrint Mimics SurgiCase CMF Guides ProPlan CMF Guides Lima PSI Materialise PKA Models Mimics Enlight CMF Materialise Mimics Enlight CMF Mimics Automatic Algorithms Knee CT Mimics Automatic Algorithms CMF CT Mimics Automatic Algorithms Knee MRI Mimics Automatic Algorithms Heart CT Mimics Plugin Segment Thin Bone HeartPrint Mimics Plugin Compare Masks Mimics Plugin RT Plugin Mimics Automatic Algorithms Torso Bones CT Mimics Automatic Algorithms Ankle CT Phits 3-matic 3-matic Medical SignatureTM Planner SignatureTM Guide SignatureTM Personalized Patient Care System SurgiCase Orthopaedics System SurgiCase Models ProPlan CMF (Orthognathic Splints) ProPlan CMF Models SurgiCase CMF Models AnatomyPrint CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides MatchPoint System TM Guides MatchPoint System TM SurgiCase CMF Guide ProPlan CMF Guide ProPlan CMF SurgiCase CMF

    Establishment Types

    Manufacture Medical Device