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Your device is a not an in vitro medical device

Not a IVDR
Fish
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

Class A
Avocado
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

Class B
Lemons
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

Class C
Oranges
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.

Class D

Your device is a Class D In Vitro medical device

Spicy Peppers
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

Rule 4b
Blue Dive
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.

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