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    <basicUdiDi>59080238554DW8S</basicUdiDi>
    <tradeName>AURILAB</tradeName>
    <deviceName>AURILAB BTE Hearing Tubes</deviceName>
    <manufacturerName>"K&amp;K CONSULTING" Krzysztof Kalinowicz</manufacturerName>
    <manufacturerSrn>PL-MF-000056504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:22:27.435Z</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>05060895630145</udiDi>
    <basicUdiDi>506089563TKB1DW</basicUdiDi>
    <tradeName>Optimax Trackball</tradeName>
    <deviceName>Trackballs and Trackpads</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>Y210906</emdnCode>
    <emdnDescription>MOUSE AND KEYBOARD EMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Optimax Trackball</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:50:25.654Z</lastUpdated>
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    <udiDi>05060614530114</udiDi>
    <basicUdiDi>506061453FallPreventionLJ</basicUdiDi>
    <tradeName>BED ALERTAMAT ONLY</tradeName>
    <deviceName>Alerta Bed Mat, Wireless c/w Transmitter</deviceName>
    <manufacturerName>Alerta Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013708</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y215199</emdnCode>
    <emdnDescription>ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:49:49.900Z</lastUpdated>
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    <udiDi>04262451171265</udiDi>
    <basicUdiDi>426245117ITE283</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITE KIT Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>142D01-02350196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:46.393Z</lastUpdated>
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    <udiDi>04262451170657</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Earnet</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>142D02 - 01350173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:42.387Z</lastUpdated>
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    <udiDi>04262451170039</udiDi>
    <basicUdiDi>426245117TIE18P</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>TIE Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010136</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:41.571Z</lastUpdated>
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    <udiDi>04050147023512</udiDi>
    <basicUdiDi>4050147JunctionBoxVIO-WN</basicUdiDi>
    <tradeName>Verbindungsbox - VIO®</tradeName>
    <deviceName>Footswitch junction box for VIO</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210999</emdnCode>
    <emdnDescription>PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20160-012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:30:07.781Z</lastUpdated>
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    <udiDi>04042809687491</udiDi>
    <basicUdiDi>4042809400386179W</basicUdiDi>
    <tradeName>Leukoplast®</tradeName>
    <deviceName>Leukoplast® eye occlusor</deviceName>
    <manufacturerName>BSN medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005787</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210336</emdnCode>
    <emdnDescription>OCCLUSION AND ANTI-RADIATION FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76467-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:21:10.450Z</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>
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    <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>
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    <udiDi>08500183433982</udiDi>
    <basicUdiDi>0850018343FOCUS6W6</basicUdiDi>
    <tradeName>Focus 640</tradeName>
    <deviceName>Focus 640</deviceName>
    <manufacturerName>Enhanced Vision Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000037120</manufacturerSrn>
    <authorisedRepresentativeName>Optelec Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2199</emdnCode>
    <emdnDescription>COMMUNICATION AND INFORMATION MANAGEMENT AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F640-UMMS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:03.247Z</lastUpdated>
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    <udiDi>00850017300576</udiDi>
    <basicUdiDi>0850017300CP8UU</basicUdiDi>
    <tradeName>Compact 8</tradeName>
    <deviceName>Compact 8</deviceName>
    <manufacturerName>Optelec Nederland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000027675</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210603</emdnCode>
    <emdnDescription>VIDEO MAGNIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP8-UMME</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:35.169Z</lastUpdated>
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    <udiDi>00850017300002</udiDi>
    <basicUdiDi>0850017300CP10KX</basicUdiDi>
    <tradeName>Compact 10 HD</tradeName>
    <deviceName>Compact 10 HD</deviceName>
    <manufacturerName>Optelec Nederland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000027675</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210603</emdnCode>
    <emdnDescription>VIDEO MAGNIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COMP-10-NSP-MD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:34.179Z</lastUpdated>
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    <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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    <udiDi>00850011150382</udiDi>
    <basicUdiDi>085001115010000114EA</basicUdiDi>
    <tradeName>Specs IC</tradeName>
    <deviceName>Specs 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>Y210999</emdnCode>
    <emdnDescription>PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000114</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:34.368Z</lastUpdated>
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    <udiDi>00850011150221</udiDi>
    <basicUdiDi>085001115080000120JA</basicUdiDi>
    <tradeName>One</tradeName>
    <deviceName>One</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>Y21450603</emdnCode>
    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80000120</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:10:30.374Z</lastUpdated>
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    <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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    <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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