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EUDAMED last updated this device on Mar 30, 2026
B-00850040295122M&S Technologies Smart System® Virtual Reality Headset System is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by M&S Technologies. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00850040295122VR-1002HUS-MF-000048924(01)00850040295122
9 warnings recorded — scroll inside the panel to see all entries.
The patient should be seated prior to doing Smart System® VR Headset, and should remain seated throughout the course of testing. If testing must occur with the patient standing up, ensure the area is clear of tripping hazards prior to the beginning of testing.
A small percentage of users may experience epileptic seizures when exposed to certain light patterns or backgrounds on a computer screen. Certain conditions may induce previously undetected epileptic symptoms even in users who have no history of prior seizures or epilepsy. Immediately discontinue use of the hardware and consult a physician if the patient experiences any of the following symptoms while using the hardware: dizziness, altered vision or muscle twitches, loss of awareness, disorientation, any involuntary movement, convulsions, or any unusual behavior or condition.
Certain patients may experience fear or anxiety at the prospect or experience of donning a VR headset. In this case, an alternative testing method is recommended.
Do not operate Smart System® VR Headset in explosive areas, in the presence of inflammable anesthetics, or volatile solvents such as alcohol, benzene or similar.
To prevent or reduce the risk of electrical shock or fire, do not expose hardware to rain or moisture. Prevent dripping, splashing, and spattering water in the vicinity of the Smart System® VR Headset and ensure that no moisture can penetrate the device.
Do not expose headset to direct sunlight, or store in an area in which it may be exposed to direct sunlight. Exposure to sunlight may cause permanent damage to the internal screen. Screen damage caused by sunlight exposure is not covered by warranty.
OTHER
Use only with the provided power supply. Using any other power supply could damage the device.
Federal law restricts the sale of this device to physicians and medical professionals only. Use of the device in procedures other than those described in this manual may result in injury.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Mar 23, 2026 | Still on market |
| Netherlands | Mar 23, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120192OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWAREPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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 →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 →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.
View in glossary →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 →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.