Materialise Ukraine, Rep. office

Registration Details

Registration Name: Materialise Ukraine, Rep. office
Registration Number: 3009555440
FEI Number: 3009555440
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Raisy Okipnoy str., 8A
City: Kyiv Kyyiv, Misto
Country: UA

Regulatory Submissions

510(k) Number: K170272

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
Plate, Bone	JEY	Class 2	Dental	No	2017-08-21
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	Class 2	Orthopedic	No	2009-11-25
Knee Arthroplasty Implantation System	OOG	Class 2	Orthopedic	No	2009-11-25
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	Class 2	Orthopedic	No	2026-03-03
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	Class 2	Orthopedic	No	2026-03-03
Shoulder Arthroplasty Implantation System	QHE	Class 2	Orthopedic	No	2022-02-04
Shoulder Prosthesis, Reverse Configuration	PHX	Class 2	Orthopedic	No	2022-02-04
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	Class 2	Orthopedic	No	2022-02-04
Cranial Surgical Planning And Instrument Guides	PPT	Class 2	Neurology	No	2026-01-30
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2020-12-10
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2019-05-28
Orthopaedic Surgical Planning And Instrument Guides	PBF	Class 2	Orthopedic	No	2017-02-07
Distometer	HMM	Class 1	Ophthalmic	No	2023-11-30
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	Class 2	Orthopedic	No	2011-05-26
Medical Device Data System	OUG	Class 1	General Hospital	No	2011-12-20
Driver, Wire, And Bone Drill, Manual	DZJ	Class 2	Dental	No	2024-08-29
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

Proprietary Names

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 Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner 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 Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Materialise TKA Guides Materialise Knee Planner Lima Personalized Surgical Instruments Materialise Knee Platform Signature Planner SurgiCase Planner Materialise Glenoid Positioning System guides Match Point System Materialise SurgiCase Planner SurgiCase Shoulder Planner AtlasPlan Shoulder System Materialise Glenoid Positioning System Match Point System guides TruMatch Personalized Solutions Shoulder Guide Materialise Shoulder Planner Materialise Shoulder Guide and Models Materialise Shoulder System ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides Materialise PKA Guides Materialise PKA Models Materialise PKA Guide System TruMatch Personalized Solutions Shoulder System Mimics Medical 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 SurgiCase Guide SurgiCase Connect SurgiCase Orthopaedics System Mimics inPrint Mimics MatchPoint System TM Guides MatchPoint System TM Lima PSI Materialise TKA Guide planner Materialise Knee Guide planner Bespoke PSI Bespoke Patient Specific Instruments Materialise Eyewear Fitting Suite Signature Personalized Patient Care System Signature Guide Mimics Enlight Materialise Mimics Enlight 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 Mimics Viewer XR Viewer SurgiCase Viewer SurgiCase Orthopaedics Materialise PKA Guide planner Mimics Enlight CMF Materialise Mimics Enlight CMF Mimics Cardiac Planner Mimics Thoracic Planner

Establishment Types

Manufacture Medical Device