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<eudamedExport entity="devices">
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    <udiDi>06956014499535</udiDi>
    <basicUdiDi>69560144CILCRQ</basicUdiDi>
    <tradeName>ShockFast</tradeName>
    <deviceName>Coronary Intravascular Lithotripsy Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629953</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:25.061Z</lastUpdated>
  </row>
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    <udiDi>06956014499528</udiDi>
    <basicUdiDi>69560144CILCRQ</basicUdiDi>
    <tradeName>ShockFast</tradeName>
    <deviceName>Coronary Intravascular Lithotripsy Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629952</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:23.909Z</lastUpdated>
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    <udiDi>06956014499511</udiDi>
    <basicUdiDi>69560144DLCZM</basicUdiDi>
    <tradeName>Lumin</tradeName>
    <deviceName>Double Lumen Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>639951</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:17.945Z</lastUpdated>
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    <udiDi>06956014499504</udiDi>
    <basicUdiDi>69560144DLCZM</basicUdiDi>
    <tradeName>Lumin</tradeName>
    <deviceName>Double Lumen Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>639950</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:15.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499108</udiDi>
    <basicUdiDi>B-06956014499108</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629910</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:14.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499092</udiDi>
    <basicUdiDi>B-06956014499092</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629909</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:13.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499085</udiDi>
    <basicUdiDi>B-06956014499085</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629908</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:07.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499078</udiDi>
    <basicUdiDi>B-06956014499078</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629907</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:05.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499061</udiDi>
    <basicUdiDi>B-06956014499061</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629906</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:04.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499054</udiDi>
    <basicUdiDi>B-06956014499054</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629905</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:03.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499047</udiDi>
    <basicUdiDi>B-06956014499047</basicUdiDi>
    <tradeName>Shun Angelkiss-A</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629904</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:56.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014499030</udiDi>
    <basicUdiDi>B-06956014499030</basicUdiDi>
    <tradeName>Shun Angelkiss</tradeName>
    <deviceName>TR-Closure Bands</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629903</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:55.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014496428</udiDi>
    <basicUdiDi>B-06956014496428</basicUdiDi>
    <tradeName>Shun Conveyor®</tradeName>
    <deviceName>Angiographic Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010101</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629642</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:53.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014496336</udiDi>
    <basicUdiDi>B-06956014496336</basicUdiDi>
    <tradeName>Shun Conveyor®</tradeName>
    <deviceName>Angiographic Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010101</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>629633</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:52.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014494035</udiDi>
    <basicUdiDi>B-06956014494035</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609403</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:45.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014494028</udiDi>
    <basicUdiDi>B-06956014494028</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609402</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:44.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014494011</udiDi>
    <basicUdiDi>B-06956014494011</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609401</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:43.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014493342</udiDi>
    <basicUdiDi>B-06956014493342</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609334</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:41.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014493335</udiDi>
    <basicUdiDi>B-06956014493335</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609333</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:34.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014493328</udiDi>
    <basicUdiDi>B-06956014493328</basicUdiDi>
    <tradeName>Shun Monitor®</tradeName>
    <deviceName>Central Venous Catheter Kit</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>609332</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:18:33.452Z</lastUpdated>
  </row>
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