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<eudamedExport entity="devices">
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    <udiDi>00850017250000</udiDi>
    <basicUdiDi>0850017250TYPE1003K7</basicUdiDi>
    <tradeName>00850017250000</tradeName>
    <deviceName>Bertec Vision Advantage (BVA) System</deviceName>
    <manufacturerName>Bertec Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000008643</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97P-0037</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:10.653Z</lastUpdated>
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  <row>
    <udiDi>D-V2C22021Z5</udiDi>
    <basicUdiDi>B-V2C22021Z5</basicUdiDi>
    <tradeName>D-V2C22021Z5</tradeName>
    <deviceName>Vesticam2</deviceName>
    <manufacturerName>Vesticam Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000047676</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V2C22021</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:12:55.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054187381041</udiDi>
    <basicUdiDi>805418738VSCSYSTR</basicUdiDi>
    <tradeName>Video-Scope wireless</tradeName>
    <deviceName>Video-Scope</deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11447</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:03:46.829Z</lastUpdated>
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  <row>
    <udiDi>08054187380983</udiDi>
    <basicUdiDi>805418738VNGSYSSW</basicUdiDi>
    <tradeName>VNG Basic wireless</tradeName>
    <deviceName>VNG</deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11463</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:03:45.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054187380815</udiDi>
    <basicUdiDi>805418738VHTPL</basicUdiDi>
    <tradeName>Synapsys VHIT Basic</tradeName>
    <deviceName>Synapsys VHIT</deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10738</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:03:40.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560072</udiDi>
    <basicUdiDi>697272756ZTVS0163</basicUdiDi>
    <tradeName>VertiSVV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007/ZT-SVV-I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:20.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560041</udiDi>
    <basicUdiDi>697272756ZTVG0249</basicUdiDi>
    <tradeName>VertiGoggles</tradeName>
    <deviceName>Vestibular function assessment device</deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:20.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972727560003</udiDi>
    <basicUdiDi>697272756ZTVM0155</basicUdiDi>
    <tradeName>VertiMobile</tradeName>
    <deviceName>Eye Movement Recording Goggles</deviceName>
    <manufacturerName>Shanghai ZEHNIT Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013234</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:16.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760449430277</udiDi>
    <basicUdiDi>376044943FVAIRE.01DC</basicUdiDi>
    <tradeName>TKM</tradeName>
    <deviceName>FAUTEUIL VESTIBULAIRE</deviceName>
    <manufacturerName>technic kine medicale</manufacturerName>
    <manufacturerSrn>FR-MF-000052186</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FVAIRE.01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:55:17.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680214</udiDi>
    <basicUdiDi>376036468FRAMI-EYEX3N</basicUdiDi>
    <tradeName>Frami-EyeXplor Module Sinusoïdal</tradeName>
    <deviceName>EYEXPLOR FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMI-EYEX-SINU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:35.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680177</udiDi>
    <basicUdiDi>376036468HPOINT.27Q</basicUdiDi>
    <tradeName>HEAD POINTER FRAMIRAL</tradeName>
    <deviceName>HEAD POINTER FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPOINT.2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:30.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680153</udiDi>
    <basicUdiDi>376036468VERSUB-EU-PCKD</basicUdiDi>
    <tradeName>FRAMI-VS</tradeName>
    <deviceName>Vertical Subjective Framiral</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VERSUB-EU-PC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:29.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680146</udiDi>
    <basicUdiDi>376036468REGLED-EUHE</basicUdiDi>
    <tradeName>REGLED Vert</tradeName>
    <deviceName>REGLED FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REGLED-EU-VERT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:28.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680078</udiDi>
    <basicUdiDi>376036468FRAMAVDN4</basicUdiDi>
    <tradeName>FRAMAVD-SSF FRAMIRAL</tradeName>
    <deviceName>Acuité Visuelle Dynamique Framiral</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMAVD2-SSF-EU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:24.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680016</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>Framiscope avec écran incorporé</tradeName>
    <deviceName>FRAMISCOPE-Vidéonystagmoscope FRAMIRAL</deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSCOPE-EU-EI2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:42:22.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680023</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>Framiscope Mini Mixte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSCOPE-EU-MM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.699Z</lastUpdated>
  </row>
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    <udiDi>03760364680030</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>Framiscope Mini Sans Fil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSCOPE-EU-MSF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.675Z</lastUpdated>
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    <udiDi>03760364680047</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>Framiscope Mini Filaire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSCOPE-EU-MFIL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.655Z</lastUpdated>
  </row>
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    <udiDi>03760364680085</udiDi>
    <basicUdiDi>376036468FRAMAVDN4</basicUdiDi>
    <tradeName>FRAMAVD-FIL FRAMIRAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMAVD2-FIL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.542Z</lastUpdated>
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    <udiDi>03760364680221</udiDi>
    <basicUdiDi>376036468FRAMI-EYEX3N</basicUdiDi>
    <tradeName>Frami-EyeXplor module vAGST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FRAMIRAL</manufacturerName>
    <manufacturerSrn>FR-MF-000011744</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAMI-EYEX-AGST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.340Z</lastUpdated>
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</eudamedExport>