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    <tradeName>Primo MA801</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
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    <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>06945936799014</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:50.145Z</lastUpdated>
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    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06945936705572</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:41.744Z</lastUpdated>
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    <tradeName>B80</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y21450603</emdnCode>
    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06945936705565</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:40.981Z</lastUpdated>
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    <tradeName>Cleartone</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705534</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:39.441Z</lastUpdated>
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    <tradeName>Huisheng</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:38.157Z</lastUpdated>
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    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:32.134Z</lastUpdated>
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    <tradeName>Puretone</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705480</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:30.948Z</lastUpdated>
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    <tradeName>Realtone</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>6945936705473</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:29.754Z</lastUpdated>
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    <udiDi>06945936705466</udiDi>
    <basicUdiDi>69459367xs005GB</basicUdiDi>
    <tradeName>TI400</tradeName>
    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705466</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:28.540Z</lastUpdated>
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    <tradeName>T1300</tradeName>
    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705459</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:22.562Z</lastUpdated>
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    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705442</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:21.343Z</lastUpdated>
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    <tradeName>TI200</tradeName>
    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936705435</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:20.138Z</lastUpdated>
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    <tradeName>TI100</tradeName>
    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:18.936Z</lastUpdated>
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    <tradeName>Poco ST</tradeName>
    <deviceName>Tinnitus Masker</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:12.942Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:12.105Z</lastUpdated>
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    <tradeName>Poco Q101</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:10.529Z</lastUpdated>
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    <tradeName>Wing 8 WP ITC</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
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    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:09.337Z</lastUpdated>
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    <tradeName>Wing 8 WP CIC</tradeName>
    <deviceName>hearing aids</deviceName>
    <manufacturerName>Xiamen NewSound Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041673</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704575</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:03.319Z</lastUpdated>
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