waveguard original

Primary DI

+B195CA003

Basic UDI-DI Code

++B195CA003PC

Reference

CA-003

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

eemagine Medical Imaging Solutions GmbH

waveguard EEG caps are intended for recording of electroencephalographic (EEG) signals, including event-related potentials (ERP) and evoked potentials (EP) on subjects or patients with intact scalp in combination with medical-grade EEG recording equipment (CE class IIa certified inside the European Union; class II device according to FDA regulations for USA). The cap must be dry and clean when used. The application of caps on subjects or patients should only be carried out by medically trained personnel (EEG technician). The technician must remain present during the entire recording session to prevent patient risks such as strangulation. Special infection control requirements may apply.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).