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Singapore HSA registration DE0507702

Materialise ProPlan CMF Guides

Singapore flagSingapore·CLASS B·Materialise N. V.·Registered January 20, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0507702
Registration Date
January 20, 2023
Change Notification Approval Date
April 30, 2024
Retention Due Date
January 19, 2026
Product description
ProPlan CMF Guides are intended to be used as surgical tools to transfer a preoperative plan to surgery. ProPlan CMF Guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
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)
Guide, Mandible (Polyamide) Guide, Bone Graft Harvesting (Polyamide) Guide, Midface (Polyamide) Guide, Distractor Positioning (Polyamide) Guide, Cranium, Forehead (Polyamide) Guide, Cranium, Frontal Bandeau (Polyamide) Guide, Cranium, Graft (Polyamide) Guide, with Planning (Polyamide)
Model Identifier(s)
SD900.101 SD900.102 SD900.104 SD900.107 SD900.108 SD900.109 SD900.110 SD900.111
About this record

Access comprehensive regulatory information for Materialise ProPlan CMF Guides in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507702 and owned by Materialise N. V.. The device was registered on January 20, 2023.

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 B