<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971162814122</udiDi>
    <basicUdiDi>697116281ST08K8</basicUdiDi>
    <tradeName>06971162814122</tradeName>
    <deviceName>Stopcock</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>MDR 2017/745</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>082001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:38:35.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841238859</udiDi>
    <basicUdiDi>697116281NE27FW</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName>Needle</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERCUTANEOUS NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>271005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:43.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841238620</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName>Guidewire</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>158144</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:43.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841227839</udiDi>
    <basicUdiDi>697116281BID10AJ</basicUdiDi>
    <tradeName>06936841227839</tradeName>
    <deviceName>Balloon Inflation Device</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:42.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841204816</udiDi>
    <basicUdiDi>697116281DC21D2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName>Drainage Catheter</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERITONAEAL DRAINAGES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:41.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841203987</udiDi>
    <basicUdiDi>697116281MF12FF</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName>Manifold</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>125003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:40.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841203970</udiDi>
    <basicUdiDi>6971162812MF126P</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName>Manifold</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:38.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841201419</udiDi>
    <basicUdiDi>697116281SY06KV</basicUdiDi>
    <tradeName>06936841201419</tradeName>
    <deviceName>Syringe</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>062001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:34:37.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841238873</udiDi>
    <basicUdiDi>69368412HV11TY</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName>Hemostasis Valve</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:14.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841238781</udiDi>
    <basicUdiDi>69368412IS05TV</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName>Introducer Sheath</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>052166</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:14.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841211869</udiDi>
    <basicUdiDi>693684123HC03G3</basicUdiDi>
    <tradeName>06936841211869</tradeName>
    <deviceName>Hemodialysis Catheter</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>033013</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:13.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205608</udiDi>
    <basicUdiDi>693684122US09MF</basicUdiDi>
    <tradeName>06936841205608</tradeName>
    <deviceName>Ureteral Stent</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SINGLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091006-4-B</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:12.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205202</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName>Hemodialysis Catheter</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:11.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841201600</udiDi>
    <basicUdiDi>69368412US09WR</basicUdiDi>
    <tradeName>06936841201600</tradeName>
    <deviceName>Ureteral Stent</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>092006-4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:10.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841201259</udiDi>
    <basicUdiDi>69368412DL00RD</basicUdiDi>
    <tradeName>06936841201259</tradeName>
    <deviceName>Dilator</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND FASCIAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>004001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:10.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841200092</udiDi>
    <basicUdiDi>B-06936841200092</basicUdiDi>
    <tradeName>06936841200092</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:52.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841200122</udiDi>
    <basicUdiDi>B-06936841200122</basicUdiDi>
    <tradeName>06936841200122</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:52.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841200207</udiDi>
    <basicUdiDi>B-06936841200207</basicUdiDi>
    <tradeName>06936841200207</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:52.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841200375</udiDi>
    <basicUdiDi>B-06936841200375</basicUdiDi>
    <tradeName>06936841200375</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></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:52.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841200382</udiDi>
    <basicUdiDi>B-06936841200382</basicUdiDi>
    <tradeName>06936841200382</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></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034007</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:52.903Z</lastUpdated>
  </row>
</eudamedExport>