Downloads Section
Documents to Download
Instructions for Use
Electrodes
Nasal Cannulas
Pastes & Gels
EEG Caps
Devices & sensors
Therapy
Certifications
ISO 13485:2016
Quality management system for medical devices.
ISO 9001:2015
Quality management system certification.
CE Marking
European conformity certification.
ISO 13485:2016
No. Q5 124981 0001 Rev. 01
Development, manufacture, and distribution of non-active and non-sterile medical devices and accessories for sleep diagnostics, oxygen therapy, neurology, and cardiology (electrodes). Import and distribution of medical devices and accessories for sleep diagnostics, oxygen therapy, neurology, and cardiology.
EU Quality Management Certificate (MDR)
No. G15 124981 0002 Rev. 00
Regulation (EU) 2017/745 on Medical Devices, Annex IX, Chapter I
Medical Device Regulation
