EE-411

Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  For the eego amplifier, 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

+B195EE411

Basic UDI-DI

++B195eegoamplifierZN

Reference / catalog number

EE-411

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

The eego amplifier is intended for acquisition of EEG signals and to transmit them digitally to a computer, and is to be used by, or under the supervision of, a qualified medical practitioner or investigator who has knowledge about the principles of EEG, physiology and potential side effects. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician’s office, etc). The device is not intended for use in life support systems.

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