<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945936702137</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Rocker 202</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>06945936702137</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:38.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936702120</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>BEE III 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>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06945936702120</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:36.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936702113</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>BEE III 400</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>06945936702113</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:35.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936702045</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VIVO 108</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>06945936702045</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:28.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936702007</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VAN 210</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>06945936702007</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:27.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701949</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo U800</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>06945936701949</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:26.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701901</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Forte 600</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>06945936701901</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:24.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701871</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VIVO 206</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>06945936701871</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:19.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701802</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>ZIV 208</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>06945936701802</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:17.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701710</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VAN PRO 201</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>06945936701710</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:16.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701666</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Forte 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>06945936701666</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:14.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701642</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>ZIV 209</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>06945936701642</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:08.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701611</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>POCO Q201</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>06945936701611</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:06.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701550</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Forte 400</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>06945936701550</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:05.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936701314</udiDi>
    <basicUdiDi>69459367xs003G7</basicUdiDi>
    <tradeName>Huisheng MCIC</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>06945936701314</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:32:04.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936700119</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Forte 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>06945936700119</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:57.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936700096</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VIVO pro 102</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>06945936700096</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:56.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936700089</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo M801</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>06945936700089</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:54.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936700027</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>VAN 201</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>06945936700027</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:53.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945936700003</udiDi>
    <basicUdiDi>69459367xs001G3</basicUdiDi>
    <tradeName>Primo M401</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>06945936700003</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:48.019Z</lastUpdated>
  </row>
</eudamedExport>