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Quality Manual & Annexes

Quality Manual & Annexes

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Responsible	Eva Kilimtzidi
Last Update	12/08/2025
Members	1

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Disclaimer: the carevix® device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use as a single-use cervical stabilizer. FDA clearance means the device has been found substantially equivalent to a legally marketed device. It does not imply endorsement or superiority. carevix® is a registered trademark of Aspivix SA. All other trademarks are the property of their respective owners. carevix® is a prescription-only device intended for use by trained healthcare professionals. As with all medical procedures, individual results may vary. Some discomfort, pain, or bleeding may still occur during or after use.
The information on this website is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Only qualified healthcare professionals should use the carevix® device. Patients should always consult their healthcare provider to determine whether carevix® is appropriate for them. Aspivix makes no warranties, express or implied, regarding the completeness, accuracy, reliability, or suitability of the information provided on this website.

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