neo monitor

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref LE-800Ref ES-820

by eemagine Medical Imaging Solutions GmbH

Identity

Trade Name: neo monitor EUDAMED
Device Name: neo monitor EUDAMED
neo monitor system EUDAMED
Model / Reference: LE-800 EUDAMED
ES-820 EUDAMED

Identifiers

Primary DI / UDI-DI: +B195LE800 EUDAMED
+B195ES820 EUDAMED
Basic UDI-DI: ++B195LE800UD EUDAMED
++B195ES820V8 EUDAMED
Direct Marketing DI: +B195LE800 EUDAMED
EMDN Code: Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Germany EUDAMED
Medical Purpose: nëo monitor is indicated for use on healthy and (critically) ill neonates to record and review the cerebral activity of newborn infants, to monitor patients for: • brain state and development • sleep-wake cycles • abnormal background patterns (burst suppression, flat trace, etc.) and for monitoring / diagnosis of patients: • with hypoxic-ischemic encephalopathy (HIE) • with clinical seizures (or suspicion thereof) • for whom there is an indication for hypothermia therapy • at high risk of brain injury NB. The device is a reusable instrument sold in a non-sterile state. Decontamination between patient monitoring episodes is advised. EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

neo monitor by Eemagine Medical Imaging Solutions Gmbh — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K192889	Class IIa	Active
EUDAMED	European Union	CE/MDR	++B195LE800UD	Class IIa	Active

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Manufacturer

Manufacturer: eemagine Medical Imaging Solutions GmbH
EUDAMED SRN: DE-MF-000005560

Sources (3)

EUDAMED fd2f44b4-3d51-49d7-9da0-4b0384dd8c6a 61 fields · synced Jul 19, 2026
EUDAMED a43aabd0-bf27-4e56-a0d0-3a9be3d3c8aa 61 fields · synced May 18, 2026
FDA 510(k) K192889 1 fields · synced May 18, 2026