Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsElectroencephalography instruments
Electroencephalography instruments - hardware accessories
EMDN code Z12100380
Manufacturers registered in Europe (EUDAMED) 19
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 50
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Advanced Brain Monitoring, Inc. Present in Europe in other categories | United States | X-Series Sleep Profiler PSG2 Sleep Profiler X-Series, X8 X8 | K152040 (2015) |
| NEURALYNX, INC. | United States | ATLAS Cart BNC Adapter Plate Global Reference Module 4 Pegasus Software License 128ch Pegasus Software License 512ch Pegasus Software License 96ch ATLAS-HS-18-CHET-A 1.0 | K110967 (2011) |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Arc Essentia Apollo Easy Ambulatory Arc | registered |
| COMPUMEDICS LIMITED Present in Europe in other categories | Australia | Compumedics Somfit Compumedics Falcon Compumedics Somfit D | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | B125M B155M B105M | registered |
| Epitel, Inc. | United States | REMI | K243185 (2025) |
| HEADSAFE MFG PTY LTD | – | Nurochek-Pro Nurochek-Pro Soft Sensor Kit Nurochek-Pro Server Nurochek-Pro Application Nurochek-Pro Headset Nurochek-Pro Saline Solution | registered |
| XLTEK | Canada | Natus | registered |
| QX WORLD LTD | Hungary | QUEX S QUEX ED | K232779 (2024) |
| Ceribell, Inc. | United States | Pocket EEG Device Pocket EEG Device, EEG Recording Viewer Software | K261101 (2026) |
| General Sleep | – | Zmachine | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | UltraviewSL | registered |
| Cerebra Medical Ltd | Canada | Cerebra Sleep System | registered |
| Neuronetrix Solutions, LLC | United States | COGNISION EEG/EP System | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | BIS Module | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BLACKROCK MICROSYSTEMS, LLC | United States | – | registered |
| BOI(VIETNAM) COMPANY LTD | Vietnam | – | registered |
| BURAK GLOBAL IC VE DIS TIC LTD STI | Türkiye | – | registered |
| Byteflies NV Present in Europe in other categories | Belgium | – | K192549 (2020) |
| Celestica Electronics (S) Pte Ltd. | Singapore | – | registered |
| Change Healthcare Canada Company Present in Europe in other categories | Canada | – | registered |
| Consolidated Research, Inc. | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Fideltronik Poland sp. z o.o. | Poland | – | registered |
| Forest Devices, Inc. | United States | – | K251726 (2025) |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| HAPPY HEALTH, INC. | United States | – | registered |
| Headsafe Holdings, Inc. | United States | – | registered |
| Hi-Tech Products de Mexico S.A. de C.V. | Mexico | – | registered |
| Hipposcreen Neurotech Corp. Present in Europe in other categories | Taiwan | – | registered |
| Jabil Inc. | United States | – | registered |
| Katecho, Inc. | United States | – | registered |
| Mindray DS USA, Inc. | United States | – | registered |
| Mirac, LLC | United States | – | registered |
| Naox Technologies Sas | France | – | K251550 (2025) |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Canada | – | K242930 (2024) |
| Neba Health, LLC | United States | – | K223628 (2023) |
| Neurosteer, Inc. | United States | – | K221563 (2022) |
| Neurowave Systems, Inc. | United States | – | K092477 (2010) |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Occam Design | United States | – | registered |
| Pascall Systems, Inc. | United States | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| Seacomp Displays | Mexico | – | registered |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | – | registered |
| Spacelabs Healthcare Present in Europe in other categories | United States | – | registered |
| TECHNICAL SERVICES FOR ELECTRONICS, INC. | United States | – | registered |
| White Dove Global Marketing, Ltd | United States | – | registered |
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Related categories
- Electroencephalographs25 manufacturers
- Electroencephalography instruments - consumables10 manufacturers
- Electroencephalography instruments - medical device software7 manufacturers
- Systems for analysing and managing EEG traces3 manufacturers
- Electroencephalography instruments - software accessories2 manufacturers
- EEG spectral analysers1 manufacturer
- Parent category : Electroencephalography instruments28 manufacturers