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<eudamedExport entity="devices">
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    <udiDi>06947752802046</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:53.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802039</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER33</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:52.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802022</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:50.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802015</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER32</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:45.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947752802008</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:43.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945095544913</udiDi>
    <basicUdiDi>69450955otoscopeTK</basicUdiDi>
    <tradeName>OT8K</tradeName>
    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000011126</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>462-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:53:36.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945095544180</udiDi>
    <basicUdiDi>69450955otoscopeTK</basicUdiDi>
    <tradeName>OT8K</tradeName>
    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000011126</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>462-1810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:50:44.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945095543909</udiDi>
    <basicUdiDi>69450955otoscopeTK</basicUdiDi>
    <tradeName>OT8V</tradeName>
    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000011126</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>468-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:49:42.118Z</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>
  <row>
    <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>
  </row>
  <row>
    <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>
  <row>
    <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>
  </row>
  <row>
    <udiDi>03760364680207</udiDi>
    <basicUdiDi>376036468MTTBCHW</basicUdiDi>
    <tradeName>Multitest Balance Control Poussant Droit</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>Z12140402</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENTSTABILOMETRIC PLATFORMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTTBC-PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.393Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>03760364680238</udiDi>
    <basicUdiDi>376036468FSCOPE-EUL7</basicUdiDi>
    <tradeName>FRAMISCOPE 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>FSCOPE-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680245</udiDi>
    <basicUdiDi>376036468FRAMAVDN4</basicUdiDi>
    <tradeName>FRAMI-AVD</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>FRAMAVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680252</udiDi>
    <basicUdiDi>376036468MTTBCHW</basicUdiDi>
    <tradeName>MULTITEST BALANCE CONTROL</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>Z12140402</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENTSTABILOMETRIC PLATFORMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTTBC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760364680276</udiDi>
    <basicUdiDi>376036468FRAMI-EYEX3N</basicUdiDi>
    <tradeName>FRAMI-EYEXPLOR</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:35.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009686</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>1096 Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:53:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009693</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>1096 Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:52:57.716Z</lastUpdated>
  </row>
</eudamedExport>