<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08721593205246</udiDi>
    <basicUdiDi>0175008/STA-ROBU/TE</basicUdiDi>
    <tradeName>Statief Robuus H-voet</tradeName>
    <deviceName>Statief Robuust</deviceName>
    <manufacturerName>rdgKompagne</manufacturerName>
    <manufacturerSrn>NL-MF-000041828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-ROBU-H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:39.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721593205239</udiDi>
    <basicUdiDi>0175008/STA-FLEX/PD</basicUdiDi>
    <tradeName>Statief Flexibel Flamingo</tradeName>
    <deviceName>Statief Flexibel</deviceName>
    <manufacturerName>rdgKompagne</manufacturerName>
    <manufacturerSrn>NL-MF-000041828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-FLEX-FLAM</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:37.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000807</udiDi>
    <basicUdiDi>018664800010000037VV</basicUdiDi>
    <tradeName>QuickTalker Feather Touch 12</tradeName>
    <deviceName>QuickTalker FT - 12</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:57.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000814</udiDi>
    <basicUdiDi>018664800010000038VX</basicUdiDi>
    <tradeName>QuickTalker FeatherTouch 23</tradeName>
    <deviceName>QuickTalker FT - 23</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:56.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000791</udiDi>
    <basicUdiDi>018664800010000036VT</basicUdiDi>
    <tradeName>QuickTalker FeatherTouch 7</tradeName>
    <deviceName>QuickTalker FT 7</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:55.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000715</udiDi>
    <basicUdiDi>018664800010034400XP</basicUdiDi>
    <tradeName>Original Receiver</tradeName>
    <deviceName>Original Receiver</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10034400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:54.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000692</udiDi>
    <basicUdiDi>018664800056100CN</basicUdiDi>
    <tradeName>Big Buddy Button Red</tradeName>
    <deviceName>Big Buddy Button Red</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>56100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:50.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000630</udiDi>
    <basicUdiDi>018664800058080DP</basicUdiDi>
    <tradeName>Mini Cup Switch</tradeName>
    <deviceName>MiniCup Switch</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:48.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000548</udiDi>
    <basicUdiDi>018664800010000031VH</basicUdiDi>
    <tradeName>SuperTalker FeatherTouch</tradeName>
    <deviceName>SuperTalker FeatherTouch</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10000031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:44.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000531</udiDi>
    <basicUdiDi>018664800010000028VU</basicUdiDi>
    <tradeName>iTalk4</tradeName>
    <deviceName>iTalk4</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:43.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000524</udiDi>
    <basicUdiDi>018664800010000032VK</basicUdiDi>
    <tradeName>TalkingBrix 2</tradeName>
    <deviceName>TalkingBrix 2</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:42.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000425</udiDi>
    <basicUdiDi>018664800010034200XD</basicUdiDi>
    <tradeName>Jelly Beamer Transmitter</tradeName>
    <deviceName>Jelly Beamer Transmitter</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10034200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:37.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000227</udiDi>
    <basicUdiDi>018664800010033500XM</basicUdiDi>
    <tradeName>Big Red</tradeName>
    <deviceName>Big Red Switch</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10033500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:31.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000203</udiDi>
    <basicUdiDi>018664800010033400XG</basicUdiDi>
    <tradeName>Jelly Bean</tradeName>
    <deviceName>Jelly Bean Switch</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10033400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:30.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00186648000180</udiDi>
    <basicUdiDi>018664800058750EH</basicUdiDi>
    <tradeName>Pillow Switch</tradeName>
    <deviceName>Pillow Switch</deviceName>
    <manufacturerName>AbleNet Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008722</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58570</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:42:29.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8962011210$</udiDi>
    <basicUdiDi>++B896BEDMOUNTSGR</basicUdiDi>
    <tradeName>M3D BM Touch</tradeName>
    <deviceName>Rehadapt bed mounts</deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20.1121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:01:54.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B89618200000</udiDi>
    <basicUdiDi>++B896KeyguardsVW</basicUdiDi>
    <tradeName>FF-GoTalkNow-10.2 2x2</tradeName>
    <deviceName>Rehadapt keyguards</deviceName>
    <manufacturerName>Rehadapt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18.2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:01:53.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B862EYEON14WE0/$2136I*</udiDi>
    <basicUdiDi>++B862EYEON14WED4</basicUdiDi>
    <tradeName>*+B862EYEON14WE0/$2136I*</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>2026-07-15T11:56:29.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+B862EYEON10NE0/$21488*</udiDi>
    <basicUdiDi>++B862EYEON10NEBM</basicUdiDi>
    <tradeName>*+B862EYEON10NE0/$21488*</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>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeOn-10NE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:29.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>PP10395R0524789</udiDi>
    <basicUdiDi>PP103951913324170</basicUdiDi>
    <tradeName>Talk Pad mit Grid for iPad</tradeName>
    <deviceName>REHAVISTA Talk Pad</deviceName>
    <manufacturerName>REHAVISTA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:41:15.379Z</lastUpdated>
  </row>
</eudamedExport>