Your device is a Class IIb medical device
What does this mean for the development effort? Please contact us to find out.
We can also provide a detailed report and certification on why your device is a Class IIb device according to MDR.
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The Classification of Medical Devices according to MDR can be ambiguous.
Xybel is not responsible for erroneous classification - either due to user-based or a tool-based error.
Please contact us for a detailed analysis.