Singapore HSA registration DE0509365
Materialise TruMatch® CMF Titanium 3D Printed Guides and Plates
Singapore·CLASS C·Materialise N. V.·Registered June 07, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C