<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08905080072874</udiDi>
    <basicUdiDi>8905080BPGW6F</basicUdiDi>
    <tradeName>Amplatz Extra Stiff Guidewire Straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAES035150ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T17:10:03.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080072881</udiDi>
    <basicUdiDi>8905080BPGW6F</basicUdiDi>
    <tradeName>Amplatz Extra Stiff Guidewire Straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAES035260ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T17:10:03.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080012160</udiDi>
    <basicUdiDi>8905080BPGW6F</basicUdiDi>
    <tradeName>Amplatz Extra Stiff Guidewire J Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAES035080JT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T17:09:49.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812579</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812579</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812586</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812586</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812593</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812593</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812623</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812623</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812630</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812630</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812685</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812685</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>156015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162812692</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812692</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>156016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162813187</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162813187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>158039</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:28.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162815051</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162815051</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:26.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162815068</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162815068</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162815891</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162815891</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>157031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162815907</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162815907</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>157032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162816096</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162816096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>158031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162816102</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162816102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>158032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971162816300</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162816300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>159032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:53:15.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080072911</udiDi>
    <basicUdiDi>8905080BPGWHZ8</basicUdiDi>
    <tradeName>Tracer Hydrophilic Guidewire Straight Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHWN035180ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:21:37.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080072928</udiDi>
    <basicUdiDi>8905080BPGWHZ8</basicUdiDi>
    <tradeName>Tracer Hydrophilic Guidewire Angled Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHWN038260AT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:21:37.850Z</lastUpdated>
  </row>
</eudamedExport>