Elekta Neuromag® TRIUX

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref NM23900N510(k) K041264

by Megin Oy

Identity

Trade Name: Elekta Neuromag® TRIUX EUDAMEDFDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: Elekta Neuromag® TRIUX EUDAMED
The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. FDA UDI
Model / Reference: NM23900N EUDAMEDFDA UDI
Description: The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. FDA UDI

Identifiers

Primary DI / UDI-DI: 06430056480008 EUDAMEDFDA UDI
Basic UDI-DI: B-06430056480008 EUDAMED
FDA Product Code: OLX FDA UDI
OLY FDA UDI
EMDN Code: Z12101201 MAGNETOENCEPHALOGRAPHY SYSTEMS EUDAMED
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
Market of Registration: Finland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Elekta Neuromag® TRIUX by Megin Oy — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K041264	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-06430056480008	Class IIa	Active

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Manufacturer

Manufacturer: Megin Oy
EUDAMED SRN: FI-MF-000011965
FDA Applicant: Elekta Neuromag OY

Sources (3)

EUDAMED 9f533fc6-2938-4b9b-86e1-21b6306619b6 85 fields · synced Jun 18, 2026
FDA UDI 64e7da61-54f5-498e-8a4c-885240291160 33 fields · synced May 30, 2026
FDA 510(k) K041264 1 fields · synced May 18, 2026