LE-200

Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

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• 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.

Primary placement in Germany; available across 31 countries total.

Trade name

not provided

UDI-DI code

+B195LE200

Basic UDI-DI

++B195LE200TF

Reference / catalog number

LE-200

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Z12100302ELECTROENCEPHALOGRAPHS

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