LE-800

Nom de l'organisation

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  The nëo monitor software does not have any contraindication, however, contraindications for the use of the nëo monitor system for recording are related to the patient’s health and general head condition. Do not use the system on persons that have/are: (1) open wound on the scalp or skin problem, (2) not able to tolerate preparation procedures, (3) not able to tolerate EEG cap/electrodes

Marché principal en Allemagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

+B195LE800

Basic UDI-DI

++B195LE800UD

Numéro de référence/catalogue

LE-800

Entité d'attribution

HIBCC

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The nëo monitor is used for electroencephalography (EEG) acquisition and review, intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days post-delivery and corresponding to a post-conceptual age of 24 to 46 weeks). The software and system on which it is installed is to be used in a hospital environment by qualified clinical practitioners. The nëo monitor provides neurophysiological data to healthcare professionals to support neurological screening, monitoring and diagnostic workflows.

URL des informations complémentaires

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

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12100302ELECTROENCEPHALOGRAPHS

• Numéro de lot
• Date d'expiration
• Date de fabrication
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• Identification du logiciel