| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05404028000199 [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 | 2025-03-17 |
| Device Publish Date | 2025-03-07 |
| 05404028001158 - Mimics Flow | 2026-03-31 Mimics Flow |
| 05404028001172 - SurgiCase Online | 2026-03-31 SurgiCase Online |
| 05404028001189 - ProPlan CMF | 2026-03-31 ProPlan CMF Online |
| 05404028000861 - Mimics Thoracic Planner | 2026-03-30 Mimics Thoracic Planner |
| 05404028000830 - Mimics Automatic Algorithms | 2026-02-09 Mimics Automatic Algorithms CMF Orthognathic CT CBCT |
| 05404028001042 - Mimics Automatic Algorithms | 2026-02-09 Mimics Automatic Algorithms CMF Reconstruction CT CBCT |
| 05404028001073 - Mimics Automatic Algorithms | 2026-02-09 Mimics Automatic Algorithms Shoulder Arthroplasty CT |
| 05404028001110 - SurgiCase Planner | 2025-12-25 SurgiCase Shoulder Planner |