EUDAMED last updated this device on Jun 24, 2026

visor2

++B1956666016N

On the marketClass IIa

Applicable legislation: —
Organization name: eemagine Medical Imaging Solutions GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B195666601
Reference / catalog number: 666601

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

visor2 is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by eemagine Medical Imaging Solutions GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: visor2
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B195666601
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. View in glossary →: ++B1956666016N
Reference / catalog number: 666601
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions in scientific research or clinical procedures. The visor2 is to be used with a compatible TMS stimulator, a compatible optical tracking system and further compatible accessories. Optionally, a compatible amplifier for measuring electrophysiological signals can be connected. The visor2 allows to record and view electrophysiological signals from the patient. It visualizes the activated functional cortex area over the anatomical images of the patient's brain based on the analysis of the patient's response after the application of a TMS pulse. The software and system on which it is installed must be operated by, or under the supervision of, a medical practitioner or investigator who has knowledge about the principles of TMS, physiology, and potential side effects, and must not be used during surgical operations.
Additional information URL: https://academy.ant-neuro.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+B195666601

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

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EMDN nomenclature code(s)

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

Z12109099VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER

Critical warnings

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

CW010
visor2 is a 3D navigation system, and, as such, has no contraindications. The TMS stimulator used with visor2 may have contraindications. Warning: Before performing transcranial magnetic stimulation, read carefully the complete list of contraindications in the documentation of your TMS stimulator.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 31 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 7, 2012	Still on market
Austria	Jun 7, 2012	Still on market
Belgium	Jun 7, 2012	Still on market
Bulgaria	Jun 7, 2012	Still on market
Cyprus	Jun 7, 2012	Still on market
Czechia	Jun 7, 2012	Still on market
Denmark	Jun 7, 2012	Still on market
Estonia	Jun 7, 2012	Still on market
EL	Jun 7, 2012	Still on market
Spain	Jun 7, 2012	Still on market
Finland	Jun 7, 2012	Still on market
France	Jun 7, 2012	Still on market
Croatia	Jun 7, 2012	Still on market
Hungary	Jun 7, 2012	Still on market
Ireland	Jun 7, 2012	Still on market
Iceland	Jun 7, 2012	Still on market
Italy	Jun 7, 2012	Still on market
Liechtenstein	Jun 7, 2012	Still on market
Lithuania	Jun 7, 2012	Still on market
Luxembourg	Jun 7, 2012	Still on market
Latvia	Jun 7, 2012	Still on market
Malta	Jun 7, 2012	Still on market
Netherlands	Jun 7, 2012	Still on market
Norway	Jun 7, 2012	Still on market
Poland	Jun 7, 2012	Still on market
Portugal	Jun 7, 2012	Still on market
Romania	Jun 7, 2012	Still on market
Sweden	Jun 7, 2012	Still on market
Slovenia	Jun 7, 2012	Still on market
Slovakia	Jun 7, 2012	Still on market
XI	Jun 7, 2012	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: visor2
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B195666601
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. View in glossary →: ++B1956666016N
Reference / catalog number: 666601
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Device details

Quantity: 1
Additional product description: The visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions in scientific research or clinical procedures. The visor2 is to be used with a compatible TMS stimulator, a compatible optical tracking system and further compatible accessories. Optionally, a compatible amplifier for measuring electrophysiological signals can be connected. The visor2 allows to record and view electrophysiological signals from the patient. It visualizes the activated functional cortex area over the anatomical images of the patient's brain based on the analysis of the patient's response after the application of a TMS pulse. The software and system on which it is installed must be operated by, or under the supervision of, a medical practitioner or investigator who has knowledge about the principles of TMS, physiology, and potential side effects, and must not be used during surgical operations.
Additional information URL: https://academy.ant-neuro.com/
Clinical sizes: No clinical sizes registered for this device.

Critical warnings

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

CW010
visor2 is a 3D navigation system, and, as such, has no contraindications. The TMS stimulator used with visor2 may have contraindications. Warning: Before performing transcranial magnetic stimulation, read carefully the complete list of contraindications in the documentation of your TMS stimulator.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 31 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 7, 2012	Still on market
Austria	Jun 7, 2012	Still on market
Belgium	Jun 7, 2012	Still on market
Bulgaria	Jun 7, 2012	Still on market
Cyprus	Jun 7, 2012	Still on market
Czechia	Jun 7, 2012	Still on market
Denmark	Jun 7, 2012	Still on market
Estonia	Jun 7, 2012	Still on market
EL	Jun 7, 2012	Still on market
Spain	Jun 7, 2012	Still on market
Finland	Jun 7, 2012	Still on market
France	Jun 7, 2012	Still on market
Croatia	Jun 7, 2012	Still on market
Hungary	Jun 7, 2012	Still on market
Ireland	Jun 7, 2012	Still on market
Iceland	Jun 7, 2012	Still on market
Italy	Jun 7, 2012	Still on market
Liechtenstein	Jun 7, 2012	Still on market
Lithuania	Jun 7, 2012	Still on market
Luxembourg	Jun 7, 2012	Still on market
Latvia	Jun 7, 2012	Still on market
Malta	Jun 7, 2012	Still on market
Netherlands	Jun 7, 2012	Still on market
Norway	Jun 7, 2012	Still on market
Poland	Jun 7, 2012	Still on market
Portugal	Jun 7, 2012	Still on market
Romania	Jun 7, 2012	Still on market
Sweden	Jun 7, 2012	Still on market
Slovenia	Jun 7, 2012	Still on market
Slovakia	Jun 7, 2012	Still on market
XI	Jun 7, 2012	Still on market

visor2

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UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

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