<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975237551080</udiDi>
    <basicUdiDi>697523755SC46</basicUdiDi>
    <tradeName>06975237551080</tradeName>
    <deviceName>Semi Automatic Coagulation Analyzer</deviceName>
    <manufacturerName>TAIZHOU STEELLEX BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023056</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SC20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:25.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974481833423</udiDi>
    <basicUdiDi>697448183010005V4</basicUdiDi>
    <tradeName>ImproClot®Thrombelastograph</tradeName>
    <deviceName>Thrombelastograph</deviceName>
    <manufacturerName>Guangzhou Improve Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006536</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>310502000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:18:17.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974481833416</udiDi>
    <basicUdiDi>697448183010004V2</basicUdiDi>
    <tradeName>ImproClot®Thrombelastograph</tradeName>
    <deviceName>Thrombelastograph</deviceName>
    <manufacturerName>Guangzhou Improve Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006536</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>310402000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:18:13.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974481833409</udiDi>
    <basicUdiDi>697448183010003UY</basicUdiDi>
    <tradeName>ImproClot®Thrombelastograph</tradeName>
    <deviceName>Thrombelastograph</deviceName>
    <manufacturerName>Guangzhou Improve Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006536</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>310302000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:18:12.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974481833393</udiDi>
    <basicUdiDi>697448183010002UW</basicUdiDi>
    <tradeName>ImproClot®Thrombelastograph</tradeName>
    <deviceName>Thrombelastograph</deviceName>
    <manufacturerName>Guangzhou Improve Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006536</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>310202000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:18:11.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974481833386</udiDi>
    <basicUdiDi>697448183010001UU</basicUdiDi>
    <tradeName>ImproClot®Thrombelastograph</tradeName>
    <deviceName>Thrombelastograph</deviceName>
    <manufacturerName>Guangzhou Improve Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006536</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>310102000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:18:11.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974020352101</udiDi>
    <basicUdiDi>697402035YK01GL</basicUdiDi>
    <tradeName>century clot</tradeName>
    <deviceName>Coagulation &amp; Platelet Function Analyzer</deviceName>
    <manufacturerName>ShijiYiKang (Tianjin) Medical Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045976</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YKCA-2, YKCA-1, YKCA-2V, YKCA-1V, YKCA-2F, YKCA-1F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:19:09.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168355459</udiDi>
    <basicUdiDi>69721683503WR</basicUdiDi>
    <tradeName>Semi-Automatic Coagulation Analyzer</tradeName>
    <deviceName>Semi-Automatic Coagulation Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9101002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:35:24.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976117455696</udiDi>
    <basicUdiDi>697049309W02020000001A2</basicUdiDi>
    <tradeName>Semi-auto Coagulation Analyzer</tradeName>
    <deviceName>Semi-auto Coagulation Analyzer</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0040-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:33:03.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289811149</udiDi>
    <basicUdiDi>69332898CE1114EP</basicUdiDi>
    <tradeName>Wondfo Optical Coagulation Analyzer</tradeName>
    <deviceName>Optical Coagulation Analyzer</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W958</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:38.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607450590418</udiDi>
    <basicUdiDi>3607450INST0006UP</basicUdiDi>
    <tradeName>STart Max</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:18.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087129</udiDi>
    <basicUdiDi>376017308BSS6</basicUdiDi>
    <tradeName>BIO SOLEA 2 - COAGULOMETER 2 CHANNELS, including accessories</tradeName>
    <deviceName>COAGULOMETER</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIOSOLEA 2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:29.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087136</udiDi>
    <basicUdiDi>376017308BSS6</basicUdiDi>
    <tradeName>BIO SOLEA 4 - COAGULOMETER 4 CHANNELS, including accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIOSOLEA 4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334802945</udiDi>
    <basicUdiDi>69503348CAA0019W</basicUdiDi>
    <tradeName>Coagulation Analyzer</tradeName>
    <deviceName>Coagulation Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA51</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:38.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334802020</udiDi>
    <basicUdiDi>69503348CAA0019W</basicUdiDi>
    <tradeName>Coagulation Analyzer</tradeName>
    <deviceName>Coagulation Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA52</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:37:08.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334801115</udiDi>
    <basicUdiDi>69503348CAA0019W</basicUdiDi>
    <tradeName>Coagulation Analyzer</tradeName>
    <deviceName>Coagulation Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA54</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:37:06.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409522</udiDi>
    <basicUdiDi>69470244001855K</basicUdiDi>
    <tradeName>Semi-auto Coagulation Analyzer</tradeName>
    <deviceName>Semi-auto Coagulation Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-2201C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:56:54.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409515</udiDi>
    <basicUdiDi>69470244005815X</basicUdiDi>
    <tradeName>Semi-auto Coagulation Analyzer</tradeName>
    <deviceName>Semi-auto Coagulation Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-2204C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:56:53.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409508</udiDi>
    <basicUdiDi>694702440057462</basicUdiDi>
    <tradeName>Semi-auto Coagulation Analyzer</tradeName>
    <deviceName>Semi-auto Coagulation Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-2202</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:56:47.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>04270003431323</udiDi>
    <basicUdiDi>42700034313MCRW</basicUdiDi>
    <tradeName>MC 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABW Medizin und Technik GmbH&amp;Co KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037096</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:26:14.338Z</lastUpdated>
  </row>
</eudamedExport>