<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06947024410467</udiDi>
    <basicUdiDi>69470244017626C</basicUdiDi>
    <tradeName>Automated Coagulation Analyzer</tradeName>
    <deviceName>Automated 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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAC-120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:59:41.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409553</udiDi>
    <basicUdiDi>69470244018786Y</basicUdiDi>
    <tradeName>Automated Coagulation Analyzer</tradeName>
    <deviceName>Automated 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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAC-2800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:57:03.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409546</udiDi>
    <basicUdiDi>69470244006115F</basicUdiDi>
    <tradeName>Automated Coagulation Analyzer</tradeName>
    <deviceName>Automated 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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAC-1800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:56:56.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947024409539</udiDi>
    <basicUdiDi>69470244003455H</basicUdiDi>
    <tradeName>Automated Coagulation Analyzer</tradeName>
    <deviceName>Automated 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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAC-050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:56:55.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770028922703</udiDi>
    <basicUdiDi>3770028922CX000U2</basicUdiDi>
    <tradeName>Coagulation Analyzer CX - 260</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770028922727</udiDi>
    <basicUdiDi>3770028922CX000U2</basicUdiDi>
    <tradeName>Coagulation Analyzer CX - 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770028922789</udiDi>
    <basicUdiDi>3770028922CX000U2</basicUdiDi>
    <tradeName>Coagulation Analyzer CX - 040</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EUBE066991200010/$8</udiDi>
    <basicUdiDi>++EUBECOAFUTHRRE</basicUdiDi>
    <tradeName>cobas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kommanditgesellschaft Behnk Elektronik GmbH &amp; Co.</manufacturerName>
    <manufacturerSrn>DE-MF-000005304</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06699120001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T13:25:55.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519825</udiDi>
    <basicUdiDi>69257945W0202020102D0KU</basicUdiDi>
    <tradeName>BCA-3000 Automatic Blood Coagulation Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014841</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:15:06.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794576262</udiDi>
    <basicUdiDi>69257945W0202020102D0KU</basicUdiDi>
    <tradeName>BCA-1000 Automatic Blood Coagulation Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3017197</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:15:04.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562425686</udiDi>
    <basicUdiDi>4987562CA-600N2</basicUdiDi>
    <tradeName>CA-620</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR142626</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:24.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562425716</udiDi>
    <basicUdiDi>4987562CA-600N2</basicUdiDi>
    <tradeName>CA-660</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK978289</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:24.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518616</udiDi>
    <basicUdiDi>4987562CN-3000LL</basicUdiDi>
    <tradeName>CN-3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL971029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518630</udiDi>
    <basicUdiDi>4987562CN-6000M9</basicUdiDi>
    <tradeName>CN-6000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV339763</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518654</udiDi>
    <basicUdiDi>4987562CS-5100P8</basicUdiDi>
    <tradeName>CS-5100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BY990757</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518661</udiDi>
    <basicUdiDi>4987562CS-2500P7</basicUdiDi>
    <tradeName>CS-2500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV981798</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518678</udiDi>
    <basicUdiDi>4987562CA-600N2</basicUdiDi>
    <tradeName>CA-620</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR142626</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518685</udiDi>
    <basicUdiDi>4987562CA-600N2</basicUdiDi>
    <tradeName>CA-660</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK978289</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074561999</udiDi>
    <basicUdiDi>8905459COAGA2Z</basicUdiDi>
    <tradeName>Merilyzer ClotQuant 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGCCAQ-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:04:52.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260182780954</udiDi>
    <basicUdiDi>426018278CAX809Z8</basicUdiDi>
    <tradeName>Coatron A6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80 920 00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:46:14.641Z</lastUpdated>
  </row>
</eudamedExport>