Product Certification - Quality Assurance

We have conducted extensive testing in compliance with EU Regulation 2019/1020. This comprises RED (Radio Equipment Directive) testing for wireless devices, ROHS (Restriction of Hazardous Substances) testing, and sterility tests (including factory inspection reports) relevant to our products. Additionally, we have obtained the corresponding CE certificate (not for medical use).

In conformance to Radio Equipment Directive (RED) 2014/53/EU, SiBio makes available these Declarations of Conformity.

References & Disclaimers

*Images across all pages are for illustrative purposes only. Not real patients or data.

*The SiBio KS1 system is not intended for medical use. Please do not use this product as a substitute for medical equipment or medical consultation.

*The SiBio KS1 system is designed for people aged 18 and older.

*The SiBio CKM app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app.

*A 60-minute warm-up is required when pairing the KS1 sensor to the SiBio CKM app.

*In order to receive ketone data, please ensure the sensor is within 20 ft of your smartphone.

*Sensor is certified to withstand being submerged in water up to 3.3 feet deep for up to 1 hour.

*The SiBio CKM app stores the last 90 days of your ketone data. For ketone data older than 90 days, please contact our customer support team.