<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06956131903632</udiDi>
    <basicUdiDi>B-06956131903632</basicUdiDi>
    <tradeName>Enduro Transmission Wire (6cm)</tradeName>
    <deviceName>Enduro Transmission Wire (6cm)</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>CP02.2136</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:43.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903618</udiDi>
    <basicUdiDi>B-06956131903618</basicUdiDi>
    <tradeName>Enduro Transmission Coil</tradeName>
    <deviceName>Enduro Transmission Coil</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>CP02.2134</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:37.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903557</udiDi>
    <basicUdiDi>B-06956131903557</basicUdiDi>
    <tradeName>Transmission Coil VENUS 60C (10cm)</tradeName>
    <deviceName>Transmission Coil VENUS 60C (10cm)</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>CP02.2042</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:35.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903540</udiDi>
    <basicUdiDi>B-06956131903540</basicUdiDi>
    <tradeName>Transmission Coil VENUS 60C (6cm)</tradeName>
    <deviceName>Transmission Coil VENUS 60C (6cm)</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>CP02.2040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:34.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903533</udiDi>
    <basicUdiDi>B-06956131903533</basicUdiDi>
    <tradeName>Programming Box</tradeName>
    <deviceName>Programming Box</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>CP00.0039</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:33.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903526</udiDi>
    <basicUdiDi>B-06956131903526</basicUdiDi>
    <tradeName>Fitting Cable USB</tradeName>
    <deviceName>Fitting Cable 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>CP00.0079</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:27.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903519</udiDi>
    <basicUdiDi>B-06956131903519</basicUdiDi>
    <tradeName>Programming Cable for Enduro</tradeName>
    <deviceName>Programming Cable for Enduro</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>CP00.0081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:26.330Z</lastUpdated>
  </row>
  <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>
</eudamedExport>