CA-142

Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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.
• CW025

  Use in MRI under condition of meeting all applicable safety and performance requirements.
• 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

+B195CA142

Basic UDI-DI

++B195waveguard9J

Reference / catalog number

CA-142

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.

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

+B195CA142

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• N01010203EEG HEADSETS