BEUDAMED
    FDA Registration Active 🇨🇴 Colombia

    Materialise Colombia S.A.S

    Reg #: 3011724582 · FEI: 3011724582 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    13

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    Registration Details

    Registration Name
    Materialise Colombia S.A.S
    Registration Number
    3011724582
    FEI Number
    3011724582
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle 29, 41-105, Loma San Julian, Edificio Soho, interior 401
    City
    Medellin Antioquia
    Country
    CO

    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
    Plate, Bone JEY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Shoulder Arthroplasty Implantation System QHE
    Cranial Surgical Planning And Instrument Guides PPT
    System, Image Processing, Radiological LLZ
    Driver, Wire, And Bone Drill, Manual DZJ
    Template HWT
    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 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 Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System AtlasPlan Shoulder System TruMatch Personalized Solutions Shoulder Guide Match Point System guides SurgiCase Shoulder Planner Materialise Glenoid Positioning System guides SurgiCase Planner Materialise Glenoid Positioning System ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides ProPlan CMF SurgiCase CMF SurgiCase SurgiCase CMF Guides ProPlan CMF Guides SurgiCase Models ProPlan CMF (Orthognathic Splints) SurgiCase CMF Models HeartPrint AnatomyPrint SurgiCase CMF Guide ProPlan CMF Guide

    Establishment Types

    Manufacture Medical Device