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Materialise TruMatch® CMF Titanium 3D Printed Guides and Plates - HSA Registration DE0509365

Access comprehensive regulatory information for Materialise TruMatch® CMF Titanium 3D Printed Guides and Plates in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509365 and owned by Materialise N. V.. The device was registered on June 07, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0509365
Materialise TruMatch® CMF Titanium 3D Printed Guides and Plates
HSA Registration Number: DE0509365
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Product Description

CMF Titanium Guides and Plates consist of osteotomy and/or drilling patient-matched guides and patient- matched plates. CMF Titanium Guides and Plates are intended for bone repositioning surgical operations for different indications: • Orthognathic surgery (Excluding children) • Reconstruction surgery CMF Titanium Guides and Plates are intended for children, adolescents and adults.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509365
Registration Date
June 07, 2024
Change Notification Approval Date
June 28, 2024
Retention Due Date
June 06, 2025
Product Owner
Short Name
Materialise N. V.
Address
Technologielaan 15, 3001 Leuven, BELGIUM
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
Titanium 3D Printed Plate for Midface Titanium 3D Printed Guide for Midface Titanium 3D Printed Plate for Mandible, Mini Titanium 3D Printed Guide for Mandible Titanium 3D Printed Plate for Mandible, Small Titanium 3D Printed Plate for Mandible, Medium Titanium 3D Printed Plate for Mandible, Large Titanium 3D Printed Guide for Orbit
Model Identifier(s)
SD980.014 SD980.015 SD980.016 SD980.017 SD980.019 SD980.020 SD980.021 SD980.104