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Singapore HSA registration DE0509366

Materialise TruMatch® CMF Titanium 3D Printed Guides and Implants

Singapore flagSingapore·CLASS C·Materialise N. V.·Registered June 07, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509366
Registration Date
June 07, 2024
Change Notification Approval Date
June 28, 2024
Retention Due Date
June 06, 2025
Product description
CMF Titanium Implants are intended for surgical operations on bones of the craniofacial skeleton. CMF Titanium Implants are intended for bone reconstruction and restoration of bone defects of the craniofacial skeleton: the cranium, frontal bone, orbital floor, wall and roof, maxilla, zygoma and mandibular bones. And more generally all defects caused by a trauma injury, tumor removal, and genetic diseases of the craniofacial skeleton. CMF Titanium Implants are intended for skeletally mature adolescents and adults.
Product Owner
Name
Materialise N. V.
Short Name
Materialise N. V.
Address
Technologielaan 15, 3001 Leuven, BELGIUM
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
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 Guide for Midface Titanium 3D Printed Guide for Mandible Titanium 3D Printed Cranial Implant, Large Titanium 3D Printed Cranial Implant, Small Titanium 3D Printed Implant for Orbit Titanium 3D Printed Guide for Orbit Titanium 3D Printed Implant for Midface, Large Titanium 3D Printed Implant for Midface, Small Titanium 3D Printed Implant for Mandible, Small Titanium 3D Printed Implant for Mandible, Medium Titanium 3D Printed Implant for Mandible, Large Titanium 3D Printed Implant for Orbit, Thin
Model Identifier(s)
SD980.015 SD980.017 SD980.101 SD980.102 SD980.103 SD980.104 SD980.105 SD980.106 SD980.107 SD980.108 SD980.109 SD980.113
About this record

Access comprehensive regulatory information for Materialise TruMatch® CMF Titanium 3D Printed Guides and Implants in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509366 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