<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06956014463659</udiDi>
    <basicUdiDi>B-06956014463659</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626365</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:55:13.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463642</udiDi>
    <basicUdiDi>B-06956014463642</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626364</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:55:07.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463635</udiDi>
    <basicUdiDi>B-06956014463635</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626363</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:55:06.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463628</udiDi>
    <basicUdiDi>B-06956014463628</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626362</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:55:04.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463611</udiDi>
    <basicUdiDi>B-06956014463611</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626361</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:55:03.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463604</udiDi>
    <basicUdiDi>B-06956014463604</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626360</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:54:57.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463598</udiDi>
    <basicUdiDi>B-06956014463598</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626359</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:54:56.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463581</udiDi>
    <basicUdiDi>B-06956014463581</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626358</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:54:55.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463574</udiDi>
    <basicUdiDi>B-06956014463574</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626357</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:54:54.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014463567</udiDi>
    <basicUdiDi>B-06956014463567</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626356</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:54:48.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701010</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701010</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW18-180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701027</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701027</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW21-180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701034</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701034</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW16-180A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701041</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW18-180A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701058</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701058</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW21-180A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701065</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701065</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW16-165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701072</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701072</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW18-165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701089</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701089</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW21-165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701096</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW16-165A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971741701102</udiDi>
    <basicUdiDi>697174170PGW0001PR</basicUdiDi>
    <tradeName>06971741701102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGW18-165A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:43:27.062Z</lastUpdated>
  </row>
</eudamedExport>