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    <tradeName>Poco RA801</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>6945936704568</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:02.138Z</lastUpdated>
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    <udiDi>06945936704544</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>Poco R401</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>6945936704544</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:35:00.922Z</lastUpdated>
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    <udiDi>06945936704537</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>Poco Q800</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>6945936704537</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:59.717Z</lastUpdated>
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    <udiDi>06945936704520</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>Poco Q400</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>6945936704520</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:53.734Z</lastUpdated>
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    <udiDi>06945936704513</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>TacTear 20</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>6945936704513</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:52.511Z</lastUpdated>
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    <udiDi>06945936704506</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>Tactear 10</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>6945936704506</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:51.328Z</lastUpdated>
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    <udiDi>06945936704490</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo M201</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704490</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:50.104Z</lastUpdated>
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    <udiDi>06945936704483</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo U400</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704483</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:44.108Z</lastUpdated>
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    <udiDi>06945936704476</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo U 200</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704476</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:42.923Z</lastUpdated>
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  <row>
    <udiDi>06945936704469</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo UA801</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704469</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:41.835Z</lastUpdated>
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    <udiDi>06945936704452</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo UA401</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704452</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:40.516Z</lastUpdated>
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    <udiDi>06945936704445</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo EA 801</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704445</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:34.522Z</lastUpdated>
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    <udiDi>06945936704438</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Forte 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>
    <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>6945936704438</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:33.312Z</lastUpdated>
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    <udiDi>06945936704421</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Medley CK</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704421</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:32.116Z</lastUpdated>
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    <udiDi>06945936704414</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Medley RK</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704414</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:30.897Z</lastUpdated>
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    <udiDi>06945936704407</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo E401</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704407</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:24.900Z</lastUpdated>
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    <udiDi>06945936704391</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo E101</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704391</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:23.694Z</lastUpdated>
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    <udiDi>06945936704384</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>ASANA PRO 200</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704384</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:22.504Z</lastUpdated>
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    <udiDi>06945936704377</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>ASANA PRO 800</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704377</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:21.423Z</lastUpdated>
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    <udiDi>06945936704360</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Rocker 203(MHB-080)</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>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945936704360</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:34:15.292Z</lastUpdated>
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