| Primary Device ID | E314MIMICSENLIGHTMED0 |
| NIH Device Record Key | 16750a35-4bf6-4d74-ac42-c94c1bcb7751 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mimics Enlight |
| Version Model Number | Mimics Enlight Medical |
| Catalog Number | Mimics Enlight Medical |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E314MIMICSENLIGHTMED0 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-05 |
| Device Publish Date | 2019-08-28 |
| 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 |