At Ophtec, we prioritize the quality and regulatory compliance of our products. Therefore, we are proud to announce that as of August 1, 2024, we will deliver the following Ophtec products under the Medical Device Regulation (MDR) 2017/745:
Product name | Model (#) | REF (Catalogue number) | |
Artiflex Myopia | 40114SW | 40114SW*** | |
Artiflex Toric | 4*0**SW | 4*0**SW*** | |
Compatible with IOLMATIC Injector System |
Non-compatible with IOLMATIC Injector System | ||
Precizon Monofocal | 560 | 56000TYP** / 56000TWP*** | 56000TY** / 56000TW*** |
Precizon Toric | 565 | 565**TYP** | 565**TY** |
Precizon Presbyopic NVA | 570 | 570A1TYP** | 570A1TY** |
Precizon Presbyopic Toric | 575 | 575A1**TYP** | 575A1**TY** |
Precizon Go | 580 | 58000TYP* |
Our commitment to safety
The European MDR is one of the strictest regulations in the world, and achieving this compliance demonstrates our commitment to the highest safety standards for our products.