<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>EPRCA0030627</udiDi>
    <basicUdiDi>++EPRC12140202BH</basicUdiDi>
    <tradeName>otosil ES-1.1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0030627</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0032528</udiDi>
    <basicUdiDi>++EPRC12140202BH</basicUdiDi>
    <tradeName>otosil ES-1.1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0032528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0033004</udiDi>
    <basicUdiDi>++EPRC12140202BH</basicUdiDi>
    <tradeName>otosil ES-1.1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0033004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0030428</udiDi>
    <basicUdiDi>++EPRC12140202BH</basicUdiDi>
    <tradeName>otosil ES-1.1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0030428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0033703</udiDi>
    <basicUdiDi>++EPRC12140202BH</basicUdiDi>
    <tradeName>otosil ES-1.1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0033703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020143</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020143</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020251</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020251</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020244</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020244</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020145</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020144</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020144</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020253</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020253</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020255</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020255</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020147</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020147</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020254</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020254</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020224</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020224</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020250</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:12.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020146</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm PU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:11.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA4020252</udiDi>
    <basicUdiDi>++EPRC12140203BK</basicUdiDi>
    <tradeName>SysTherm ECO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4020252</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:45:11.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923601285024</udiDi>
    <basicUdiDi>69236012ZENIZINCAIR001KY</basicUdiDi>
    <tradeName>ZeniPower</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai ZhiLi Battery Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001782</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A312/PR41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:21.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923601285031</udiDi>
    <basicUdiDi>69236012ZENIZINCAIR001KY</basicUdiDi>
    <tradeName>ZeniPower</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai ZhiLi Battery Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001782</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A13/PR48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:21.919Z</lastUpdated>
  </row>
</eudamedExport>