visor2

EUDAMED

Class IIa (EU MDR)

Ref ES-600

Identity

Primary DI / UDI-DI: +B195ES600 EUDAMED
Basic UDI-DI: ++B195ES600UQ EUDAMED
EMDN Code: Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED

Device Class: Class IIa EUDAMED
Medical Purpose: visor2 is used to aid 3D navigation for positioning Transcranial Magnetic Stimulation (TMS) coil over preselected brain regions based on data from MRI measurements or scalp landmarks. • To locate motor areas and to facilitate the recording of motor-evoked potentials (MEPs) in clinical conditions where associated neurological pathways are investigated. • Clinical conditions where motor mapping is required (for example- pre-surgical planning). • To locate language-specific and non-specific areas. • Treatment resistant major depressive disorder (MDD), where TMS is prescribed. Note: Specifically for clinical procedures: positioning over anatomical and functional areas for which the use of the TMS coil is intended under applicable regulations. In addition, visor2 can be used in a broad range of neuroscience applications and fundamental research like neurology, neuropsychology, neuropsychiatry to study brain function. visor2 is a reusable device sold in a nonsterile state. Decontamination of the pointer tool between the sessions is advised. EUDAMED

Sterile

EUDAMED

visor2 by Eemagine Medical Imaging Solutions Gmbh — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++B195ES600UQ	Class IIa	Active

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