Skip to content
Emdyca

Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsElectroencephalography instruments

Electroencephalography instruments - medical device software

EMDN code Z12100392

7 manufacturers, 10 models including 10 on the market, 7 countries

Export to CSV
Manufacturers registered in Europe (EUDAMED) 7
  • 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.
ManufacturerCountryRegistered modelsClassContact
Cerenion Finland IIb MDR Website info@cerenion.com EUDAMED record Report an error
Compumedics FDA EU representative : Compumedics EUROPE GmbH (Germany) Australia IIa MDR Website EUDAMED record Report an error
Persyst FDA EU representative : MDSS GmbH (Germany) United States IIa MDR Website EUDAMED record Report an error
Alphatrace Austria IIa 93/42 Website office@alphatrace.at EUDAMED record Report an error
CergenX Ireland IIb MDR Website info@cergenx.com EUDAMED record Report an error
HippoScreen Neurotech FDA EU representative : Luana Med. B.V. (Netherlands) Taiwan IIa MDR EUDAMED record Report an error
Kvikna FDA Iceland IIa MDR Website EUDAMED record Report an error

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) 10

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.

ManufacturerCountryBrandsFDA clearance
XLTEK Canada Natus XLTEK registered
AIT Austrian Institute of Technology GmbH Austria encevis K240993 (2024)
Ceribell, Inc. United States Pocket EEG Device Pocket EEG Device, EEG Recording Viewer Software K260998 (2026)
LVIS CORPORATION United States NeuroMatch K241390 (2024)
Epitel, Inc. United States REMI Vigilenz K240408 (2024)
Holberg Eeg AS Present in Europe in other categories Norway Autoscore K243743 (2025)
Austrian Institute of Technology GmbH Austria – K211452 (2021)
Natus Medical Incorporated Present in Europe in other categories United States – K090019 (2010)
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Canada – K200878 (2020)
Nihon Kohden America, Inc. Present in Europe in other categories United States – registered

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Related categories