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EUDAMED last updated this device on May 21, 2026
++B195waveguard9Jwaveguard is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. 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.
+B195CY271CY-271+B195CY271
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
N01010203EEG HEADSETS3 warnings recorded — scroll inside the panel to see all entries.
The caps should not be used on patients with skin injuries or problems such as blisters, burns, wounds from operation or other superficial wounds or transmissible diseases, such as – but not limited to – hepatitis, human immunodeficiency virus (HIV) or Creutzfeldt-Jacob disease. In the event of defibrillation, disconnect the cap and/or electrodes from the EEG recording equipment first.
Do not use the cap in a Magnetic Resonance Imaging (MRI) scanner or in any other high-intensity electromagnetic field radiation environment unless the type of the cap expressly states the compatibility with such a device.
The application of caps on subjects or patients should only be carried out by medically trained personnel (EEG technician). The technician must remain present during the entire recording session to prevent patient risks such as strangulation. Special infection control requirements may apply.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 22, 2017 | Still on market |
DE-MF-000005560Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 →No certificate specifically references this device's Basic UDI-DI.
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 →Certificate health across this manufacturer's portfolio.
44911222111IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →