<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06959809601809</udiDi>
    <basicUdiDi>B-06959809601809</basicUdiDi>
    <tradeName>Implantable Extension Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Extension Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:08.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601793</udiDi>
    <basicUdiDi>B-06959809601793</basicUdiDi>
    <tradeName>Single Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Single Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02010102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, NOT RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G101A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:07.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601786</udiDi>
    <basicUdiDi>B-06959809601786</basicUdiDi>
    <tradeName>Dual Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Dual Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02010102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, NOT RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:06.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601779</udiDi>
    <basicUdiDi>B-06959809601779</basicUdiDi>
    <tradeName>Dual Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Dual Channel Implantable Pulse Generator Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02010101</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G102R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:00.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131904035</udiDi>
    <basicUdiDi>B-06956131904035</basicUdiDi>
    <tradeName>Sterile non-magnetic metal plug</tradeName>
    <deviceName>Sterile non-magnetic metal plug</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>CP00.0063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:31.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131904028</udiDi>
    <basicUdiDi>B-06956131904028</basicUdiDi>
    <tradeName>Enduro Waterproof case</tradeName>
    <deviceName>Enduro Waterproof 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>CP02.2176</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:25.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903960</udiDi>
    <basicUdiDi>B-06956131903960</basicUdiDi>
    <tradeName>VENUS 60C BTE Battery Extension Wire (40cm)</tradeName>
    <deviceName>VENUS 60C BTE Battery Extension Wire (40cm)</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>CP02.1036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:23.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903953</udiDi>
    <basicUdiDi>B-06956131903953</basicUdiDi>
    <tradeName>VENUS 60C BTE Battery Extension Wire (20cm)</tradeName>
    <deviceName>VENUS 60C BTE Battery Extension Wire (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>CP02.1034</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:22.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903939</udiDi>
    <basicUdiDi>B-06956131903939</basicUdiDi>
    <tradeName>Enduro Signal processing unit button assembly</tradeName>
    <deviceName>Enduro Signal processing unit button assembly</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>CP02.2148</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:21.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903922</udiDi>
    <basicUdiDi>B-06956131903922</basicUdiDi>
    <tradeName>Enduro Charging Stand</tradeName>
    <deviceName>Enduro 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>CP02.2130</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:15.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903908</udiDi>
    <basicUdiDi>B-06956131903908</basicUdiDi>
    <tradeName>Enduro Rechargeable BTE Battery</tradeName>
    <deviceName>Enduro 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>CP02.2132</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:14.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903878</udiDi>
    <basicUdiDi>B-06956131903878</basicUdiDi>
    <tradeName>Enduro Remote Control</tradeName>
    <deviceName>Enduro Remote Control</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>CP02.2145</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:13.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903861</udiDi>
    <basicUdiDi>B-06956131903861</basicUdiDi>
    <tradeName>Enduro Earhook</tradeName>
    <deviceName>Enduro Earhook</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>CP02.2147</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:11.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903816</udiDi>
    <basicUdiDi>B-06956131903816</basicUdiDi>
    <tradeName>Enduro External Magnet (8#)</tradeName>
    <deviceName>Enduro 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>CP02.2127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:05.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903809</udiDi>
    <basicUdiDi>B-06956131903809</basicUdiDi>
    <tradeName>Enduro External Magnet (6#)</tradeName>
    <deviceName>Enduro 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>CP02.2126</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:04.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903793</udiDi>
    <basicUdiDi>B-06956131903793</basicUdiDi>
    <tradeName>Enduro External Magnet (5#)</tradeName>
    <deviceName>Enduro 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>CP02.2125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:03.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903786</udiDi>
    <basicUdiDi>B-06956131903786</basicUdiDi>
    <tradeName>Enduro External Magnet (4#)</tradeName>
    <deviceName>Enduro 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>CP02.2124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:22:02.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903779</udiDi>
    <basicUdiDi>B-06956131903779</basicUdiDi>
    <tradeName>Enduro External Magnet (3#)</tradeName>
    <deviceName>Enduro 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>CP02.2123</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:56.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903762</udiDi>
    <basicUdiDi>B-06956131903762</basicUdiDi>
    <tradeName>Enduro External Magnet (2#)</tradeName>
    <deviceName>Enduro 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>CP02.2122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:55.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956131903755</udiDi>
    <basicUdiDi>B-06956131903755</basicUdiDi>
    <tradeName>Enduro External Magnet (1#)</tradeName>
    <deviceName>Enduro External Magnet (1#)</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>CP02.2121</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:21:53.942Z</lastUpdated>
  </row>
</eudamedExport>