<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>06956131903007</udiDi>
    <basicUdiDi>B-06956131903007</basicUdiDi>
    <tradeName>VENUS 60C External magnet 5#</tradeName>
    <deviceName>VENUS 60C External magnet 5#</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>CP02.2048</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:37.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902994</udiDi>
    <basicUdiDi>B-06956131902994</basicUdiDi>
    <tradeName>VENUS 60C External magnet 4#</tradeName>
    <deviceName>VENUS 60C External magnet 4#</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>CP02.2047</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:35.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902987</udiDi>
    <basicUdiDi>B-06956131902987</basicUdiDi>
    <tradeName>VENUS 60C External magnet 3#</tradeName>
    <deviceName>VENUS 60C External magnet 3#</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>CP02.2046</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:28.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902970</udiDi>
    <basicUdiDi>B-06956131902970</basicUdiDi>
    <tradeName>VENUS 60C External magnet 2#</tradeName>
    <deviceName>VENUS 60C External magnet 2#</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>CP02.2045</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:27.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902963</udiDi>
    <basicUdiDi>B-06956131902963</basicUdiDi>
    <tradeName>Transmission Coil VENUS 60C (28cm)</tradeName>
    <deviceName>Transmission Coil VENUS 60C (28cm)</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>CP02.2044</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:26.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902956</udiDi>
    <basicUdiDi>B-06956131902956</basicUdiDi>
    <tradeName>Transmission Coil VENUS 60C (20cm)</tradeName>
    <deviceName>Transmission Coil VENUS 60C (20cm)</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>CP02.2043</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:25.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902949</udiDi>
    <basicUdiDi>B-06956131902949</basicUdiDi>
    <tradeName>Transmission Coil VENUS 60C (8cm)</tradeName>
    <deviceName>Transmission Coil VENUS 60C (8cm)</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>CP02.2041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:19.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902932</udiDi>
    <basicUdiDi>B-06956131902932</basicUdiDi>
    <tradeName>VENUS Speech Processor Unit NSP – 60C</tradeName>
    <deviceName>VENUS Speech Processor Unit 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>CP02.2057</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:17.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131902086</udiDi>
    <basicUdiDi>B-06956131902086</basicUdiDi>
    <tradeName>Medical Tape</tradeName>
    <deviceName>Medical Tape</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>CP00.0067</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:16.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131901638</udiDi>
    <basicUdiDi>B-06956131901638</basicUdiDi>
    <tradeName>COCHLEAR IMPLANT CS-10A (TM)</tradeName>
    <deviceName>COCHLEAR IMPLANT CS-10A (TM)</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>CP01.0019</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:15.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131901584</udiDi>
    <basicUdiDi>B-06956131901584</basicUdiDi>
    <tradeName>COCHLEAR IMPLANT CS-10A (SD)</tradeName>
    <deviceName>COCHLEAR IMPLANT CS-10A (SD)</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>CP01.0016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:08.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131901577</udiDi>
    <basicUdiDi>B-06956131901577</basicUdiDi>
    <tradeName>COCHLEAR IMPLANT CS-10A (TL)</tradeName>
    <deviceName>COCHLEAR IMPLANT CS-10A (TL)</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>CP01.0020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:07.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131901560</udiDi>
    <basicUdiDi>B-06956131901560</basicUdiDi>
    <tradeName>COCHLEAR IMPLANT CS-10A (TS)</tradeName>
    <deviceName>COCHLEAR IMPLANT CS-10A (TS)</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>P01.0018</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:05.900Z</lastUpdated>
  </row>
</eudamedExport>