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Emdyca

Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsElectroencephalography instruments

Electroencephalography instruments - software accessories

EMDN code Z12100382

2 manufacturers, 2 models including 2 on the market, 2 countries

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Holberg EEG FDA Norway IIa MDR Website EUDAMED record Report an error
Natus FDA EU representative : Natus Manufacturing Ltd (Ireland) Canada 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) 9

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
Persyst Development Corporation Present in Europe in other categories United States Persyst 14 Review and Analysis Software Persyst Mobile App Persyst 15 EEG Review and Analysis Software Persyst 13 EEG Review and Analysis Software Persyst 12 EEG Review and Analysis Software K252160 (2025)
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)
Austrian Institute of Technology GmbH Austria – K211452 (2021)
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Canada – K200878 (2020)
Nihon Kohden America, Inc. Present in Europe in other categories United States – registered

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