<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10705036013389</udiDi>
    <basicUdiDi>0705036a0004974</basicUdiDi>
    <tradeName>PROXIMATE</tradeName>
    <deviceName>PROXIMATE Reloadable Vascular Linear Cutter with Safety Lock-out</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TVC55</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:52.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036003311</udiDi>
    <basicUdiDi>0705036a000456U</basicUdiDi>
    <tradeName>PROXIMATE</tradeName>
    <deviceName>Proximate Reloadable Linear Stapler</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H020201010102</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX30B</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:24.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036003045</udiDi>
    <basicUdiDi>0705036a0004872</basicUdiDi>
    <tradeName>PROXIMATE</tradeName>
    <deviceName>PROXIMATE Linear Cutter Reload</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H0202010302</emdnCode>
    <emdnDescription>SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITHOUT BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCR10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:23.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036003052</udiDi>
    <basicUdiDi>0705036a000476Y</basicUdiDi>
    <tradeName>PROXIMATE</tradeName>
    <deviceName>PROXIMATE Reloadable Linear Cutter with Safety Lock-out</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCT10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:22.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036002826</udiDi>
    <basicUdiDi>0705036a000726X</basicUdiDi>
    <tradeName>ETHICON</tradeName>
    <deviceName>Linear Cutter Reloads</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H0202010301</emdnCode>
    <emdnDescription>SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR55</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:20.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036002611</udiDi>
    <basicUdiDi>0705036a000396Z</basicUdiDi>
    <tradeName>ETHICON</tradeName>
    <deviceName>ETHICON Linear Cutter</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H020201010102</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTLC55</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:10.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912012</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912012</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH752</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:49.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912111</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912111</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH753</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:20.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912210</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912210</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH754</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:19.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912029</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912029</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH1002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:13.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912128</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912128</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH1003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:11.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298912227</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298912227</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH1004</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:10.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930009</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK552</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:51.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930108</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930108</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK553</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:51.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930207</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930207</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK554</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:46.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930016</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930016</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK752</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:45.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930115</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930115</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK753</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:44.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930214</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930214</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK754</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:43.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930023</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930023</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK1002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:42.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949298930122</udiDi>
    <basicUdiDi>69492989LS0002W7</basicUdiDi>
    <tradeName>06949298930122</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Brightness Medical Devices Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019184</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020201010101</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GK1003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:41.643Z</lastUpdated>
  </row>
</eudamedExport>