XC-210

Nom de l'organisation

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Statut du fabricant

Actif

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• 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.

Marché principal en Allemagne ; disponible dans 31 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

+B195XC210

Basic UDI-DI

++B195waveguard9J

Numéro de référence/catalogue

XC-210

Entité d'attribution

HIBCC

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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

URL des informations complémentaires

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

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12100380ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES

Santé des certificats sur le portefeuille de ce fabricant.