CE Compliance of VitaeChek Devices
All VitaeChek devices meet the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and are CE marked for marketing in the European market.
Risk Class
VitaeChek G1 Pro glucometers and Pulse 3 blood pressure monitors are classified as Class IIa Medical Devices. This classification ensures the highest level of control for personal diagnostic devices, with supervision by a European notified body.
Applicable Standards
- ISO 15197:2015 — In vitro blood glucose monitoring system (98% compliance)
- EN ISO 81060-2 — Non-invasive sphygmomanometers (ESH validation)
- EU Regulation 2017/745 (MDR) — Medical Devices
- RoHS Directive — Restriction of Hazardous Substances
Declaration of Conformity
Complete technical documentation and CE declarations of conformity are available upon request for competent authorities, healthcare professionals, and authorized dealers.
Contact: support@vitaechek.com
Subject: CE Documentation Request — [Product]
