CE compliance of VitaeChek devices
VitaeChek devices sold as medical devices carry the CE marking, which allows them to be marketed in the European Union. On every pack and in the user manual you will find the CE mark, the manufacturer's details and, where required, the notified body number.
Devices and classification
- Gluco G1 Pro and G1 Pro test strips — blood glucose self-monitoring system: in vitro diagnostic medical devices (IVD) with CE marking.
- Pulse 3 — automatic upper-arm blood pressure monitor: medical device with CE marking.
- Body composition scales (Brio 1 Pro, B1 Mini) — wellness devices: body composition values are estimates with no diagnostic purpose. They are not medical devices.
Correct use
Always read the warnings and instructions for use before using the device. The devices are used to measure and record values at home and do not replace your doctor's advice. In an emergency, call 112.
Declaration of conformity and documentation
EU declarations of conformity and technical documentation are available on request for competent authorities, healthcare professionals and resellers.
Contact: vitaechek@gmail.com
Subject: CE documentation request — [Product]
Reporting incidents
If you suspect that a device malfunction has had consequences for someone's health, write to us immediately at vitaechek@gmail.com stating the product, lot number and what happened: the report is handled according to the vigilance procedures required for medical devices.
