NA-415

Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  The caps should not be used on patients with skin injuries or problems such as blisters, burns, wounds from operation or other superficial wounds or transmissible diseases, such as – but not limited to – hepatitis, human immunodeficiency virus (HIV) or Creutzfeldt-Jacob disease. In the event of defibrillation, disconnect the cap and/or electrodes from the EEG recording equipment first.
• CW027

  Do not use the cap in a Magnetic Resonance Imaging (MRI) scanner or in any other high-intensity electromagnetic field radiation environment unless the type of the cap expressly states the compatibility with such a device.
• CW030

  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.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

+B195NA415

Basic UDI-DI

++B195waveguard9J

Reference / catalog number

NA-415

Issuing entity

HIBCC

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

"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."

Additional information URL

https://academy.ant-neuro.com/knowledge-center/product-documents

Clinical sizes

No clinical sizes registered for this device.

• N01010203EEG HEADSETS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification