<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06956131903502</udiDi>
    <basicUdiDi>B-06956131903502</basicUdiDi>
    <tradeName>Programming Cable for VENUS (NSP-60C)</tradeName>
    <deviceName>Programming Cable for VENUS (NSP-60C)</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:25.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903489</udiDi>
    <basicUdiDi>B-06956131903489</basicUdiDi>
    <tradeName>Enduro Signal Processing Unit</tradeName>
    <deviceName>Enduro Signal Processing Unit</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.2131</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:23.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903311</udiDi>
    <basicUdiDi>B-06956131903311</basicUdiDi>
    <tradeName>Software NuroSound NS V1.0 (USB)</tradeName>
    <deviceName>Software NuroSound NS V1.0 (USB)</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:17.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903298</udiDi>
    <basicUdiDi>B-06956131903298</basicUdiDi>
    <tradeName>Drying Case</tradeName>
    <deviceName>Drying Case</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:16.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903281</udiDi>
    <basicUdiDi>B-06956131903281</basicUdiDi>
    <tradeName>Elastic Bandage</tradeName>
    <deviceName>Elastic Bandage</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0065</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:15.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903267</udiDi>
    <basicUdiDi>B-06956131903267</basicUdiDi>
    <tradeName>Plastic Card</tradeName>
    <deviceName>Plastic Card</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0066</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:14.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903212</udiDi>
    <basicUdiDi>B-06956131903212</basicUdiDi>
    <tradeName>VENUS 60C BTE Battery Extension Wire (30cm)</tradeName>
    <deviceName>VENUS 60C BTE Battery Extension Wire (30cm)</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1035</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:08.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903182</udiDi>
    <basicUdiDi>B-06956131903182</basicUdiDi>
    <tradeName>Implant magnet</tradeName>
    <deviceName>Implant magnet</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP01.0017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:07.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903144</udiDi>
    <basicUdiDi>B-06956131903144</basicUdiDi>
    <tradeName>RF Signal Tester</tradeName>
    <deviceName>RF Signal Tester</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:05.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903120</udiDi>
    <basicUdiDi>B-06956131903120</basicUdiDi>
    <tradeName>VENUS 60C Battery Storage Body-worn Bag</tradeName>
    <deviceName>VENUS 60C Battery Storage Body-worn Bag</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:04.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903113</udiDi>
    <basicUdiDi>B-06956131903113</basicUdiDi>
    <tradeName>VENUS 60C BTE Microphone cover &amp; filter</tradeName>
    <deviceName>VENUS 60C BTE Microphone cover &amp; filter</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:58.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903106</udiDi>
    <basicUdiDi>B-06956131903106</basicUdiDi>
    <tradeName>VENUS 60C Earhook for BTE</tradeName>
    <deviceName>VENUS 60C Earhook for BTE</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:57.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903083</udiDi>
    <basicUdiDi>B-06956131903083</basicUdiDi>
    <tradeName>BTE Charger Power Cable</tradeName>
    <deviceName>BTE Charger Power Cable</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP00.0026</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:56.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903076</udiDi>
    <basicUdiDi>B-06956131903076</basicUdiDi>
    <tradeName>UE Plug Adaptor for BTE Batteries Charger</tradeName>
    <deviceName>UE Plug Adaptor for BTE Batteries Charger</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1045</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:55.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903069</udiDi>
    <basicUdiDi>B-06956131903069</basicUdiDi>
    <tradeName>VENUS 60C BTE Batteries Charging Stand</tradeName>
    <deviceName>VENUS 60C BTE Batteries Charging Stand</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1046</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:49.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903052</udiDi>
    <basicUdiDi>B-06956131903052</basicUdiDi>
    <tradeName>VENUS 60C Connection wire for Rechargeable Body-worn Battery</tradeName>
    <deviceName>VENUS 60C Connection wire for Rechargeable Body-worn Battery</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:47.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903045</udiDi>
    <basicUdiDi>B-06956131903045</basicUdiDi>
    <tradeName>VENUS 60C Body-worn Rechargeable Battery</tradeName>
    <deviceName>VENUS 60C Body-worn Rechargeable Battery</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1039</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:46.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903038</udiDi>
    <basicUdiDi>B-06956131903038</basicUdiDi>
    <tradeName>VENUS 60C Rechargeable BTE Battery</tradeName>
    <deviceName>VENUS 60C Rechargeable BTE Battery</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.1038</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:45.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903021</udiDi>
    <basicUdiDi>B-06956131903021</basicUdiDi>
    <tradeName>VENUS 60C External magnet 8#</tradeName>
    <deviceName>VENUS 60C External magnet 8#</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.2050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:39.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903014</udiDi>
    <basicUdiDi>B-06956131903014</basicUdiDi>
    <tradeName>VENUS 60C External magnet 6#</tradeName>
    <deviceName>VENUS 60C External magnet 6#</deviceName>
    <manufacturerName>Zhejiang Nurotron Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013332</manufacturerSrn>
    <authorisedRepresentativeName>Biotech Innovation &amp; Solutions S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000010974</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0301</emdnCode>
    <emdnDescription>COCHLEAR IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP02.2049</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:38.293Z</lastUpdated>
  </row>
</eudamedExport>