ISO CERTIFICATION ISO 9001 & EN 13485 certified. The highest European Standards are followed in the manufacture of Dermatude’s Meta-Ject FX50 device. Dermatude is manufactured in an ISO 9001 certified facility and meets the European Union Medical Standard EN 13485. The company’s digital device, patented* disposable needle modules, products and comprehensive training offer the beauty professional the ability to perform procedures easily, safely and efficiently. Dermatude offers a unique compact device that includes a superior set of product features that are distinguished by specific benefits for different business settings.