XC-001

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.

• 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.
• 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.

Primary placement in Germany; available across 31 countries total.

Trade name

not provided

UDI-DI code

+B195XC001

Basic UDI-DI

++B195waveguard9J

Reference / catalog number

XC-001

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 accessories are part of the waveguard family of products, with the intended purpose to record EEG signals.

Additional information URL

https://academy.ant-neuro.com/

Clinical sizes

No clinical sizes registered for this device.

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

+B195XC001

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

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

• Z12100380ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES