LE-200

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

  For the eego software, no contra-indications are given. The system in which it is used may have contraindications for its intended purpose. For example, in the use of the eego system contra-indications 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 31 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

+B195LE200

Basic UDI-DI

++B195LE200TF

Numéro de référence/catalogue

LE-200

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

eego is used for electroencephalography (EEG) acquisition and review, intended to record and display EEG for evaluation of the data as recorded or processed, e.g., as event-related potentials (ERP). The software and system on which it is installed is to be used by, or under the supervision of, a qualified medical practitioner or investigator who has knowledge about the principles of EEG/ERP, physiology and potential side effects. eego provides neurophysiological data to healthcare professionals to support examinations in neurology, neuropsychology or neuropsychiatry.

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
• Numéro de série
• Identification du logiciel