Preci-Health Secures MDR Certificate from TÜV SÜD for ezdraw™

January 26th, 2026 | Neuchâtel, Switzerland

Preci-Health, developer of ezdraw™, a breakthrough needle-free blood collection technology, proudly announces successful CE marking certification under the European Medical Device Regulation (MDR, Regulation (EU) 2017/745) issued by notified body TÜV SÜD Product Service (CE 0123). This certification marks a significant milestone, demonstrating that all Preci-Health’s design, development, and manufacturing processes comply fully with stringent MDR requirements. 

“This achievement is a result of the expertise and dedication of our team” said Patrick Berdoz, Co-Founder and CEO at Preci-Health. 

The certification by TÜV SÜD Product Service confirms that Preci-Health has implemented a robust quality management system that aligns with the latest EU regulatory standards, ensuring the safety, performance, and reliability of its devices chanelling capillary blood without needles into compatible tubes. It’s designed for use by Health Care Professionals in hospitals, clinics, laboratories, pharmacies, and in the future for remote procedures at home. 

This certificate will clearly accelerate the introduction of ezdraw™ on the market. The device aims to simplify the blood collection experience by combining two tubes in one draw, solving key challenges in phlebotomy — from patient discomfort to improving caregiver workload.

About Preci-Health

Preci-Health, a Swiss-based medtech and AI innovator, is redefining the $80 billion in vitro diagnostics (IVD) industry with ezdraw™ — an advanced blood sampling solution that eliminates the need for trained phlebotomists. Designed for both at-clinic and at-home use, ezdraw™ offers unparalleled convenience and precision, making it a game-changer in remote healthcare.

Media Contact:

Laurence Blazianu, CBO, l.blazianu@precihealth.com 

Philippine Berdoz, BD Manager and US Representative, philippine.berdoz@precihealth.com 

Documentation: View our MDR Certificate