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<eudamedExport entity="devices">
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    <udiDi>05908809923801</udiDi>
    <basicUdiDi>59088099238Tik-Tak_ProKV</basicUdiDi>
    <tradeName>Tik-Tak Pro</tradeName>
    <deviceName>Tik-Tak Pro</deviceName>
    <manufacturerName>UHURA BIONICS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000056617</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>Tik Tak Pro 1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:23:09.823Z</lastUpdated>
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    <udiDi>05060895630817</udiDi>
    <basicUdiDi>506089563SWS1H6</basicUdiDi>
    <tradeName>Smoothie 125 Red (Large Jack)</tradeName>
    <deviceName>Assistive Switches</deviceName>
    <manufacturerName>Pretorian Technologies Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008344</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMOO5LJR</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:50:26.457Z</lastUpdated>
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    <udiDi>00860012896806</udiDi>
    <basicUdiDi>08600128968PARLEZEL55</basicUdiDi>
    <tradeName>Parlez™ Electrolarynx</tradeName>
    <deviceName>Electrolarynx (Artificial Larynx)</deviceName>
    <manufacturerName>Elogio Speech Technologies LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052790</manufacturerSrn>
    <authorisedRepresentativeName>Europecert UG (haftungsbeschränkt)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PARLEZ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:59.245Z</lastUpdated>
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    <udiDi>00860011726708</udiDi>
    <basicUdiDi>08600117268GTVJ</basicUdiDi>
    <tradeName>GoTalk 20+ Lite Touch</tradeName>
    <deviceName>GoTalk Product Line</deviceName>
    <manufacturerName>Attainment Company, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043650</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTL-20</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:51.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850057368007</udiDi>
    <basicUdiDi>0850057368ElectroLarynxD2</basicUdiDi>
    <tradeName>10850057368007</tradeName>
    <deviceName>ElectroLarynx</deviceName>
    <manufacturerName>ENT Solutions LLC</manufacturerName>
    <manufacturerSrn>US-MF-000037670</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214212</emdnCode>
    <emdnDescription>VOICE GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL 1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:36.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011150399</udiDi>
    <basicUdiDi>085001115010000115EC</basicUdiDi>
    <tradeName>Buddy Button IC</tradeName>
    <deviceName>Buddy Button IC</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>10000115</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:35.166Z</lastUpdated>
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  <row>
    <udiDi>00850011150214</udiDi>
    <basicUdiDi>085001115080000118JP</basicUdiDi>
    <tradeName>Quick Ready Mounting Plate for Assistive Technology</tradeName>
    <deviceName>Quick Ready Mounting Plate for Assistive Technology</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>80000118</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:29.563Z</lastUpdated>
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    <udiDi>00850011150344</udiDi>
    <basicUdiDi>085001115010000077EV</basicUdiDi>
    <tradeName>BIG Candy Corn 2</tradeName>
    <deviceName>BIG Candy Corn 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>Y214299</emdnCode>
    <emdnDescription>DEVICES FOR INTERPERSONAL COMUNICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000077</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:28.772Z</lastUpdated>
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  <row>
    <udiDi>00850011150252</udiDi>
    <basicUdiDi>085001115080000123JG</basicUdiDi>
    <tradeName>Cling</tradeName>
    <deviceName>Cling</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>Artık piyasada değil</deviceStatus>
    <reference>80000123</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:27.971Z</lastUpdated>
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  <row>
    <udiDi>00850011150184</udiDi>
    <basicUdiDi>085001115010000050E9</basicUdiDi>
    <tradeName>BIG TalkingBrix</tradeName>
    <deviceName>BIG TalkingBrix</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>10000050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:11.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011150108</udiDi>
    <basicUdiDi>085001115010000045EG</basicUdiDi>
    <tradeName>iTalk2</tradeName>
    <deviceName>iTalk2</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>10000045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:10.316Z</lastUpdated>
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  <row>
    <udiDi>00850011150092</udiDi>
    <basicUdiDi>085001115010000044EE</basicUdiDi>
    <tradeName>LITTLE Step-by-Step</tradeName>
    <deviceName>LITTLE Step-by-Step</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>10000044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:09.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011150085</udiDi>
    <basicUdiDi>085001115010000043EC</basicUdiDi>
    <tradeName>BIG Step-by-Step</tradeName>
    <deviceName>BIG Step-by-Step</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>10000043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:08.702Z</lastUpdated>
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  <row>
    <udiDi>00850011150078</udiDi>
    <basicUdiDi>085001115010000042EA</basicUdiDi>
    <tradeName>LITTLEmack</tradeName>
    <deviceName>LITTLEmack</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>10000042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:04.900Z</lastUpdated>
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  <row>
    <udiDi>00850011150061</udiDi>
    <basicUdiDi>085001115010000041E8</basicUdiDi>
    <tradeName>BIGmack</tradeName>
    <deviceName>BIGmack</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>10000041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:04.852Z</lastUpdated>
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  <row>
    <udiDi>08721593205413</udiDi>
    <basicUdiDi>0175008/COM-SPEECHPB/AU</basicUdiDi>
    <tradeName>Communicatie Speechpack B TouchToTell</tradeName>
    <deviceName>Communicatie Speechpack B</deviceName>
    <manufacturerName>rdgKompagne</manufacturerName>
    <manufacturerSrn>NL-MF-000041828</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>COM-SPEECHPB-TTT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:57.297Z</lastUpdated>
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    <udiDi>08721593205352</udiDi>
    <basicUdiDi>0175008/ELEK-MAATW/FE</basicUdiDi>
    <tradeName>Elektro Maatwerk</tradeName>
    <deviceName>Elektro Maatwerk</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>ELEK-MAATW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:49.291Z</lastUpdated>
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    <udiDi>08721593205345</udiDi>
    <basicUdiDi>0175008/WTB-MAATW/CZ</basicUdiDi>
    <tradeName>WTB Maatwerk</tradeName>
    <deviceName>WTB Maatwerk</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>WTB-MAATW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:48.491Z</lastUpdated>
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    <udiDi>08721593205321</udiDi>
    <basicUdiDi>0175008/OST-KOJO/YB</basicUdiDi>
    <tradeName>Kojo Up</tradeName>
    <deviceName>Ontwikkeling, Spel en Therapie - Kojo</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>OST-KOJO-UP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:44.520Z</lastUpdated>
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    <udiDi>08721593205284</udiDi>
    <basicUdiDi>0175008/STA-TAFEL/9C</basicUdiDi>
    <tradeName>Statief Tafel Beugel</tradeName>
    <deviceName>Statief Tafel</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-TAFEL-B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:48:41.286Z</lastUpdated>
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</eudamedExport>