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Regulatory Information

Regulatory documentation can be found in this section. Please review it carefully before using your Byteflies Kit or its accessories. Note that some accessories are medical devices in their own right, but they were specifically designed to work well with Byteflies Kits.

When reviewing information in the Byteflies Help Center, always make sure to verify the document label:

CE mark

This part of the documentation is covered by a medical device CE mark.


Investigational Use Only

This part of the documentation describes information that can be used by trained healthcare professionals only under an Investigational Device Exemption (IDE) or similar institutional approval.


Convenience

This part of the documentation is provided for your convenience. It is not covered by a regulatory clearance or an an investigational use case.


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