Your device is a not an in vitro 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 not an in vitro diagnostics medical device according to IVDR.
Contact us for a free sample report.
Disclaimer
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.
Your device is a Class A in vitro 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 A device according to IVDR.
Contact us for a free sample report.
Disclaimer
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.
Your device is a Class B in vitro 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 B device according to IVDR.
Contact us for a free sample report.
Disclaimer
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.
Your device is a Class C in vitro 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 C device according to IVDR.
Contact us for a free sample report.
Disclaimer
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.
Your device is a Class D In Vitro 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 D device according to IVDR.
Contact us for a free sample report.
Disclaimer
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.
Your device is Classified in its own right
What does this mean for the development effort? Please contact us to find out.
Contact us for a free sample report.
Disclaimer
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.