Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

+B195LE800

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Consult instructions for use

  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

Primary placement in Germany; available across 32 countries total.

Trade name

neo monitor

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

+B195LE800

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

++B195LE800UD

Reference / catalog number

LE-800

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12100302ELECTROENCEPHALOGRAPHS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.