<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B862EYEON12WC0/$2218F</udiDi>
    <basicUdiDi>++B862EYEON12WCCN</basicUdiDi>
    <tradeName>+B862EYEON12WC0/$2218F</tradeName>
    <deviceName>EyeOn Air</deviceName>
    <manufacturerName>EyeTech Digital Systems</manufacturerName>
    <manufacturerSrn>US-MF-000035001</manufacturerSrn>
    <authorisedRepresentativeName>EyeTech Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023070</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeOn-12WC</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:22.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B862EYEON14WE0D</udiDi>
    <basicUdiDi>++B862EYEON14WED4</basicUdiDi>
    <tradeName>+B862EYEON14WE0D</tradeName>
    <deviceName>EyeOn Elite</deviceName>
    <manufacturerName>EyeTech Digital Systems</manufacturerName>
    <manufacturerSrn>US-MF-000035001</manufacturerSrn>
    <authorisedRepresentativeName>EyeTech Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023070</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214224</emdnCode>
    <emdnDescription>AUGMENTATIVE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeOn-14WE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:20.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B862EYEON10NE/$21512*</udiDi>
    <basicUdiDi>++B862EYEON10NEBM</basicUdiDi>
    <tradeName>+B862EYEON10NE/$21512*</tradeName>
    <deviceName>EyeOn Go</deviceName>
    <manufacturerName>EyeTech Digital Systems</manufacturerName>
    <manufacturerSrn>US-MF-000035001</manufacturerSrn>
    <authorisedRepresentativeName>EyeTech Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023070</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214224</emdnCode>
    <emdnDescription>AUGMENTATIVE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeOn-10NE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:06.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024116035</udiDi>
    <basicUdiDi>843702411602EBSLC</basicUdiDi>
    <tradeName>Oskol iPad</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRISBOND CROWDBONDING, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000004335</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.PP00.LEGACY</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:18:05.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024116042</udiDi>
    <basicUdiDi>843702411602EBSLC</basicUdiDi>
    <tradeName>Oskol 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRISBOND CROWDBONDING, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000004335</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.PP01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:20.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024116004</udiDi>
    <basicUdiDi>843702411602EBSLC</basicUdiDi>
    <tradeName>Oskol Windows</tradeName>
    <deviceName>Oskol Windows S10</deviceName>
    <manufacturerName>IRISBOND CROWDBONDING, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000004335</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.WW01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:47:54.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059571380396</udiDi>
    <basicUdiDi>805957138MISWBA00E8</basicUdiDi>
    <tradeName>Baleno Player</tradeName>
    <deviceName>Software per la Comunicazione Aumentativa Alternativa</deviceName>
    <manufacturerName>Mesa Ideas SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029839</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214224</emdnCode>
    <emdnDescription>AUGMENTATIVE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MISWBA00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:46:53.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024116028</udiDi>
    <basicUdiDi>843702411602EBSLC</basicUdiDi>
    <tradeName>Oskol Windows S7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IRISBOND CROWDBONDING, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000004335</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.WW00.LEGACY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:15:03.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059571380495</udiDi>
    <basicUdiDi>805957138MISWBA00E8</basicUdiDi>
    <tradeName>Baleno Player</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mesa Ideas SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029839</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214224</emdnCode>
    <emdnDescription>AUGMENTATIVE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MISWBA00-p</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:01.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961000010Y</udiDi>
    <basicUdiDi>++B896RehadapterKR</basicUdiDi>
    <tradeName>Rehadapter™ Mk-I INT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10.0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961000040.</udiDi>
    <basicUdiDi>++B896RehadapterKR</basicUdiDi>
    <tradeName>Rehadapter™ Mk-II EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10.0004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961000050</udiDi>
    <basicUdiDi>++B896RehadapterKR</basicUdiDi>
    <tradeName>Rehadapter™ Mk-II INT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10.0005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961001000Y</udiDi>
    <basicUdiDi>++B896RehadapterKR</basicUdiDi>
    <tradeName>Rehadapter™ Pro Mk-I EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10.0100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961001010Z</udiDi>
    <basicUdiDi>++B896RehadapterKR</basicUdiDi>
    <tradeName>Rehadapter™ Pro Mk-I INT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10.0101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110210</udiDi>
    <basicUdiDi>++B896FrameClampsK3</basicUdiDi>
    <tradeName>M3D RKL F125</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110220$</udiDi>
    <basicUdiDi>++B896FrameClampsK3</basicUdiDi>
    <tradeName>M3D RKL F150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:58.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110230/</udiDi>
    <basicUdiDi>++B896FrameClampsK3</basicUdiDi>
    <tradeName>M3D RKL F250</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:57.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110240+</udiDi>
    <basicUdiDi>++B896FrameClampsK3</basicUdiDi>
    <tradeName>M3D T-Nut 20 x 6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:57.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110400$</udiDi>
    <basicUdiDi>++B896FrameClampsK3</basicUdiDi>
    <tradeName>M3D RKL Care Bed Dali/Lippe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:57.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8961110520%</udiDi>
    <basicUdiDi>++B896WallMountsUR</basicUdiDi>
    <tradeName>M3D Wallmount Base Parallel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.1052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:57:57.874Z</lastUpdated>
  </row>
</eudamedExport>