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    <basicUdiDi>0850057368ElectroLarynxD2</basicUdiDi>
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    <deviceName></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 1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:11.422Z</lastUpdated>
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    <udiDi>04262544480014</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad Pro M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad Pro M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.852Z</lastUpdated>
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    <udiDi>04262544480021</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.835Z</lastUpdated>
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    <udiDi>04262544480038</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad School</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad School</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.819Z</lastUpdated>
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    <udiDi>04262544480045</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.798Z</lastUpdated>
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  <row>
    <udiDi>04262544480052</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad Mini G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad Mini G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.779Z</lastUpdated>
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  <row>
    <udiDi>04262544480069</udiDi>
    <basicUdiDi>426254448rpadTQ</basicUdiDi>
    <tradeName>r-Pad Pro G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RETEACA Reha- und Kommunikationstechnik</manufacturerName>
    <manufacturerSrn>DE-PR-000050976</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>r-Pad Pro G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:05:08.760Z</lastUpdated>
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  <row>
    <udiDi>04260764320370</udiDi>
    <basicUdiDi>426076432HEPROEye47</basicUdiDi>
    <tradeName>HE PROEye GoTalkNow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</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>2159</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:50.618Z</lastUpdated>
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  <row>
    <udiDi>04260764320363</udiDi>
    <basicUdiDi>426076432HEPROEye47</basicUdiDi>
    <tradeName>HE PROEye Predictable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</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>1646</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:49.717Z</lastUpdated>
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  <row>
    <udiDi>04260764320356</udiDi>
    <basicUdiDi>426076432HEPROEye47</basicUdiDi>
    <tradeName>HE PROEye MetaTalkAT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</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>2070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:48.821Z</lastUpdated>
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    <udiDi>04260764320332</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X12 Assistive Express</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:47.018Z</lastUpdated>
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    <udiDi>04260764320325</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X12 Predictable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:46.116Z</lastUpdated>
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  <row>
    <udiDi>04260764320318</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X12 MetaTalk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:45.213Z</lastUpdated>
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  <row>
    <udiDi>04260764320301</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X12 GoTalkNow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:44.312Z</lastUpdated>
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  <row>
    <udiDi>04260764320295</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X10 Assistive Express</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:43.415Z</lastUpdated>
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  <row>
    <udiDi>04260764320288</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X10 Predictable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:42.515Z</lastUpdated>
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  <row>
    <udiDi>04260764320271</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X10 MetaTalk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:41.611Z</lastUpdated>
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    <udiDi>04260764320264</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X10 GoTalkNow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:40.709Z</lastUpdated>
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    <udiDi>04260764320257</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X8 Assistive Express</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:39.810Z</lastUpdated>
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    <udiDi>04260764320240</udiDi>
    <basicUdiDi>426076432HEKOMMUNBASICXEZ</basicUdiDi>
    <tradeName>Basic X8 Predictable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Humanelektronik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214209</emdnCode>
    <emdnDescription>ALPHABETIC AND SYMBOLIC COMMUNICATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:39:38.918Z</lastUpdated>
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