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    <udiDi>07640183760136</udiDi>
    <basicUdiDi>B-07640183760136</basicUdiDi>
    <tradeName>directSTIM Port Plug</tradeName>
    <deviceName>Port Plug</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020180</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:52.523Z</lastUpdated>
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    <udiDi>07640183760068</udiDi>
    <basicUdiDi>B-07640183760068</basicUdiDi>
    <tradeName>directSTIM External Pulse Generator</tradeName>
    <deviceName>directSTIM External Pulse Generator</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:29.256Z</lastUpdated>
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    <udiDi>07640183760037</udiDi>
    <basicUdiDi>B-07640183760037</basicUdiDi>
    <tradeName>directSTIM 12-connector extension</tradeName>
    <deviceName>directSTIM 12-connector extension kit</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:23.644Z</lastUpdated>
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    <udiDi>07640183760020</udiDi>
    <basicUdiDi>B-07640183760020</basicUdiDi>
    <tradeName>directSTIM 24-channel Implantable Pulse Generator</tradeName>
    <deviceName>directSTIM 24-channel Implantable Pulse Generator</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02010101</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:22.834Z</lastUpdated>
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    <udiDi>07640183760013</udiDi>
    <basicUdiDi>B-07640183760013</basicUdiDi>
    <tradeName>directSTIM 12-electrode lead</tradeName>
    <deviceName>directSTIM 12-electrode lead kit</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:22.039Z</lastUpdated>
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    <udiDi>04260479770781</udiDi>
    <basicUdiDi>426047977022426</basicUdiDi>
    <tradeName>EASEE System</tradeName>
    <deviceName>EASEE System</deviceName>
    <manufacturerName>Precisis Gesellschaft mit beschränkter Haftung</manufacturerName>
    <manufacturerSrn>DE-MF-000016826</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESC003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:39:55.574Z</lastUpdated>
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  <row>
    <udiDi>06959809601892</udiDi>
    <basicUdiDi>B-06959809601892</basicUdiDi>
    <tradeName>Test Stimulator</tradeName>
    <deviceName>Test Stimulator</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>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:29.046Z</lastUpdated>
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  <row>
    <udiDi>06959809601885</udiDi>
    <basicUdiDi>B-06959809601885</basicUdiDi>
    <tradeName>Clinician Programmer</tradeName>
    <deviceName>Clinician Programmer</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>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSM1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:27.837Z</lastUpdated>
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  <row>
    <udiDi>06959809601878</udiDi>
    <basicUdiDi>B-06959809601878</basicUdiDi>
    <tradeName>Patient Programmer Recharger</tradeName>
    <deviceName>Patient Programmer Recharger</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>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:26.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601861</udiDi>
    <basicUdiDi>B-06959809601861</basicUdiDi>
    <tradeName>Patient Programmer</tradeName>
    <deviceName>Patient Programmer</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>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:25.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601854</udiDi>
    <basicUdiDi>B-06959809601854</basicUdiDi>
    <tradeName>Test Extension Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Test 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>TE01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:19.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601847</udiDi>
    <basicUdiDi>B-06959809601847</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead 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>L302S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:18.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959809601830</udiDi>
    <basicUdiDi>B-06959809601830</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead 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>L301S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:17.027Z</lastUpdated>
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  <row>
    <udiDi>06959809601823</udiDi>
    <basicUdiDi>B-06959809601823</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead 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>L302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:15.833Z</lastUpdated>
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    <udiDi>06959809601816</udiDi>
    <basicUdiDi>B-06959809601816</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead 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>L301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:09.832Z</lastUpdated>
  </row>
  <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>
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    <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>
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  <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>
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