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Emdyca

Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments

Video/electronystagmographs

EMDN code Z12120124

8 manufacturers, 14 models including 14 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • 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
Natus FDA Denmark I, IIa MDR Website EUDAMED record Report an error
P³Lab Belgium I, IIa MDR Website info@neuroclues.com EUDAMED record Report an error
Difra FDA Belgium I 93/42 Website info@difra.be EUDAMED record Report an error
G. Heinemann Medizintechnik Germany IIa 93/42 Website info@heinemann-ent.de EUDAMED record Report an error
Gruppo Audiologico Italy I MDR commerciale@gruppoaudiologico.com EUDAMED record Report an error
Neurobittech FDA EU representative : KOMAS Medical Technology GmbH (Germany) Taiwan I MDR info@neurobittech.com EUDAMED record Report an error
Sibbo Medical Devices Finland I MDR Website info@sibbomedicaldevices.com EUDAMED record Report an error
Zeisberg Germany I 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) 24

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
Interacoustics A/S Present in Europe in other categories Denmark Interacoustics K200534 (2020)
MEDTRONIC PS MEDICAL, INC. United States EXTERNAL DRAINAGE MONITORING Becker registered
INVENTIS SRL Present in Europe in other categories Italy VNG Synapsys VHIT K242726 (2025)
MEDTRAK VNG, INC. United States MedTrakVNG MobiTrak System MobiTrakVNG Receiver MedTrakVNG Footswitch MedTrakVNG Interface Controller MedTrakVNG Goggle MobiTrak Software v3.00 registered
N K I – I-Portal Super VNG I-Portal Portable Assessment System Neuro Kinetics Inc registered
Vestibular First United States Vestibular First K203082 (2020)
Micromedical Technologies, Inc. United States Micromedical Technologies K964646 (1997)
Spryson America, Inc. United States Neurolign Dx NOTC Neurolign Dx SVNG Neurolign Dx100 registered
Synapsys, Inc. United States Complete Monocular wireless Smart Cam system with Goggles Flex Complete Monocular wireless Smart Cam system with Xpress mask Kinetic Wi-Fi wireless VNG Ulmer system with Goggles Flex K163558 (2017)
Ecleris United States VNG 3D registered
WESTERN SYSTEMS RESEARCH INC. United States ENGplus™ VAT® K010059 (2001)
ISEN Tech. & Trading Co., Ltd. China ISEN-Goggles K152727 (2016)
NEUROSYNC INC. United States EYE-SYNC registered
Righteye, LLC United States RightEye Vision System K181771 (2018)
DEMANT A/S Denmark – registered
Dizzydoctor Systems, LLC United States – K182214 (2018)
Ebi, L.P. United States – registered
Isent Tech & Trading Company, Ltd. China – K163270 (2017)
Maxway Technology Co., Ltd. China – registered
Neuro Kinetics, Inc. United States – K181025 (2018)
Neuroears, Inc. South Korea – K243709 (2025)
Neurolign USA, LLC United States – K192186 (2019)
Syncthink, Inc. United States – K152915 (2016)
VertigoDx, Inc. United States – K260566 (2026)

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