Materialise Mimics Enlight Materialise Mimics Enlight

GUDID 05404028000199

Materialise Mimics Enlight

Materialise NV

CAD/CAM software

• Primary Device ID: 05404028000199
• NIH Device Record Key: 0d175656-312f-4b1d-8de0-d45215af06cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Materialise Mimics Enlight
• Version Model Number: Materialise Mimics Enlight
• Catalog Number: Materialise Mimics Enlight
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404028000199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190874

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-17
• Device Publish Date: 2025-03-07

Devices Manufactured by Materialise NV

• 05404028000199 - Materialise Mimics Enlight: 2025-03-17Materialise Mimics Enlight
• 05404028000199 - Materialise Mimics Enlight: 2025-03-17 Materialise Mimics Enlight
• 05404028000281 - SurgiCase OOS: 2025-03-17 SurgiCase Mobile
• 05420060380747 - TRUMATCH: 2025-03-10 Titanium 3D Printed Guide, Bone harvesting
• 05420060380754 - TRUMATCH: 2025-03-10 Mandible Reconstruction kit
• 05420060380761 - TRUMATCH: 2025-03-10 Midface Reconstruction kit
• 05420060366116 - Match Point System: 2024-12-17 Guide and Bone model for Reverse Shoulder Arthroplasty (AltiVate® Reverse)
• 05420060366123 - Match Point System: 2024-12-17 Guide and Bone model for Total Shoulder Arthroplasty (AltiVate® Full Wedge)
• 05404028000090 - Mimics: 2024-12-11 Mimics Automatic Algorithms Knee MRI