Instruments for functional explorations and therapeutic interventionsENT instrumentsVestibular system analysis instruments
Vestibular assessment systems
EMDN code Z12140401
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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Framiral | France | I MDR | Website contact@framiral.fr EUDAMED record Report an error | |
| Inventis FDA | Italy |
|
IIa MDR | Website quality@inventis.it EUDAMED record Report an error |
| BioMed Jena | Germany | IIa 93/42 | Website eudamed@biomed-jena.de EUDAMED record Report an error | |
| Zehnit EU representative : Lotus NL B.V. (Netherlands) | China | I, IIa MDR | Website info@zehnit.cn EUDAMED record Report an error | |
| Bertec FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | IIa MDR | Website info@bertec.com EUDAMED record Report an error | |
| Vesticam EU representative : Compliance Management Solutions Europe LTD (Bulgaria) | Australia |
|
I 93/42 | info@vesticam.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) 28
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 |
|---|---|---|---|
| Natus Medical Denmark ApS Present in Europe in other categories | Denmark | GN Otometrics A/S Otometrics 1091, ICS Dizcovery ShadeShift Panels 1091, ICS Dizcovery Universal Face Cushion (qty 40) 1091, ICS Dizcovery LCD Panels 1091, ICS Dizcovery System | K242198 (2025) |
| Instrumentation Difra SA Present in Europe in other categories | United States | Instrumentation Difra SA Instrumentation Difra Intrumentation Difra | K070670 (2007) |
| Interacoustics A/S Present in Europe in other categories | Denmark | Interacoustics | K200534 (2020) |
| MEDTRONIC PS MEDICAL, INC. | United States | EXTERNAL DRAINAGE MONITORING Becker | registered |
| 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 |
| NATUS MANUFACTURING LIMITED Present in Europe in other categories | Ireland | ICS Impulse Vision Denied Solution 2 Kit (200 pcs) ICS Impulse Vision Denied Solution 2 Kit (50 pcs) | 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 |
| Natus Medical Incorporated Present in Europe in other categories | United States | – | registered |
| Neuro Kinetics, Inc. | United States | – | K181025 (2018) |
| Neurobit Technologies Co., Ltd. Present in Europe in other categories | Taiwan | – | K223047 (2023) |
| 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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