Materialise Sdn Bhd

Registration Details

Registration Name: Materialise Sdn Bhd
Registration Number: 3009555447
FEI Number: 3009555447
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Unit 5-01, Menara Obyu, No. 4, Jalan PJU 8/8A, Damansara Perdana,
City: Petaling Jaya Selangor
Country: MY

Regulatory Submissions

510(k) Number: K241143

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	Device Class	Medical Specialty	Exempt	Created
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	Class 2	Orthopedic	No	2024-06-18
Shoulder Prosthesis, Reverse Configuration	PHX	Class 2	Orthopedic	No	2024-06-18
Shoulder Arthroplasty Implantation System	QHE	Class 2	Orthopedic	No	2024-06-18
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2026-03-16
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	Class 2	Orthopedic	No	2015-08-19
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	Class 2	Orthopedic	No	2015-08-19
Knee Arthroplasty Implantation System	OOG	Class 2	Orthopedic	No	2015-08-19
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	Class 2	Orthopedic	No	2015-08-19
Cranial Surgical Planning And Instrument Guides	PPT	Class 2	Neurology	No	2026-01-30
Driver, Wire, And Bone Drill, Manual	DZJ	Class 2	Dental	No	2025-02-26
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2017-12-04
Distometer	HMM	Class 1	Ophthalmic	No	2023-11-30
Oral Airway Assist	PHS	Class 1	Anesthesiology	No	2023-05-23
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	MBV	Class 2	Orthopedic	No	2014-04-30
Plate, Bone	JEY	Class 2	Dental	No	2018-09-07
Neurological Stereotaxic Instrument	HAW	Class 2	Neurology	No	2012-04-11
Orthopaedic Surgical Planning And Instrument Guides	PBF	Class 2	Orthopedic	No	2012-08-02
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	Class 2	Orthopedic	No	2011-05-26

Proprietary Names

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 Lima Personalized Surgical Instruments SurgiCase Shoulder Planner Materialise Glenoid Positioning System guides SurgiCase Planner Materialise Glenoid Positioning System Mimics Thoracic Planner Materialise TKA Guide System Materialise TKA Guides SurgiCase Knee Planner Materialise SurgiCase Knee Module Materialise Knee Planner Materialise Knee Guides Materialise Knee Guide planner Materialise Knee Platform Bespoke PSI Materialise Knee Guide System Materialise TKA Guide planner Bespoke Patient Specific Instruments Materialise SurgiCase Knee Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner ProPlan CMF SurgiCase CMF SurgiCase ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides 3-matic 3-matic Medical Materialise PKA Guides Materialise PKA Guide planner Materialise PKA Guide System Signature Guides Materialise TKA Guides and Models Signature Planner BKS Total PSI Materialise TKA Guide Planner Zimmer Biomet Patient Specific Instruments Materialise Eyewear Fitting Suite Signature Personalized Patient Care System Signature Guide Lima PSI TruMatch Personalized Solutions Shoulder System Materialise PKA Models TruMatch CMF Titanium 3D Printed Implant System TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants SurgiCase CMF Guide ProPlan CMF Guide SurgiCase Connect SurgiCase Guide SurgiCase Orthopaedics Mimics Enlight CMF Materialise Mimics Enlight CMF Mimics Cardiac Planner SurgiCase CMF Guides ProPlan CMF Guides

Establishment Types

Manufacture Medical Device