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<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>04035479190538</udiDi>
    <basicUdiDi>4035479BUDI00002PN</basicUdiDi>
    <tradeName>SW HMSC 3.66</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOTRONIK SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J010792</emdnCode>
    <emdnDescription>ACTIVE IMPLANTABLE CARDIAC DEVICES REMOTE MONITORING SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>498092</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:11:38.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000181352</udiDi>
    <basicUdiDi>0763000B00003637M</basicUdiDi>
    <tradeName>N/A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900280</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS - HARDWARE ACCESSORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2090ECL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:38:37.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000834470</udiDi>
    <basicUdiDi>0763000B00002006Q</basicUdiDi>
    <tradeName>MyCareLink™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900203</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:35:58.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000834487</udiDi>
    <basicUdiDi>0763000B00002006Q</basicUdiDi>
    <tradeName>MyCareLink™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900203</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:35:58.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000834494</udiDi>
    <basicUdiDi>0763000B00002006Q</basicUdiDi>
    <tradeName>MyCareLink™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900203</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:35:58.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000834500</udiDi>
    <basicUdiDi>0763000B00002006Q</basicUdiDi>
    <tradeName>MyCareLink™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900203</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:35:58.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000834517</udiDi>
    <basicUdiDi>0763000B00002006Q</basicUdiDi>
    <tradeName>MyCareLink™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01900203</emdnCode>
    <emdnDescription>IMPLANTABLE CARDIAC DEVICES PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:35:58.347Z</lastUpdated>
  </row>
</eudamedExport>