<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R01016YS</udiDi>
    <basicUdiDi>B-R01016YS</basicUdiDi>
    <tradeName>D-R01016YS</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01016</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:51:06.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01015YQ</udiDi>
    <basicUdiDi>B-R01015YQ</basicUdiDi>
    <tradeName>D-R01015YQ</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:51:05.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01014YN</udiDi>
    <basicUdiDi>B-R01014YN</basicUdiDi>
    <tradeName>D-R01014YN</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:51:04.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01013YL</udiDi>
    <basicUdiDi>B-R01013YL</basicUdiDi>
    <tradeName>D-R01013YL</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:51:03.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01012YJ</udiDi>
    <basicUdiDi>B-R01012YJ</basicUdiDi>
    <tradeName>D-R01012YJ</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:50:59.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01011YG</udiDi>
    <basicUdiDi>B-R01011YG</basicUdiDi>
    <tradeName>D-R01011YG</tradeName>
    <deviceName>Prothrombin Time Assay Reagent Kit (Coagulation Method)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:50:58.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762575</udiDi>
    <basicUdiDi>697134876234B25752F</basicUdiDi>
    <tradeName>D-dimer Control</tradeName>
    <deviceName>D-dimer Control</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-234</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:38:20.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013016779</udiDi>
    <basicUdiDi>505601300PTMR</basicUdiDi>
    <tradeName>Thromboplastin L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5267L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:27:18.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013017424</udiDi>
    <basicUdiDi>505601300PTMR</basicUdiDi>
    <tradeName>Thromboplastin L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5265HL</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:27:18.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155007811</udiDi>
    <basicUdiDi>B-18430155007811</basicUdiDi>
    <tradeName>FIBRINÓGENO</tradeName>
    <deviceName>FIBRINÓGENO</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999430</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:37:45.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053163323</udiDi>
    <basicUdiDi>69449040AB75000075X</basicUdiDi>
    <tradeName>Antithrombin III (AT Ⅲ) Assay Kit (Chromogenic  Substrate Method)</tradeName>
    <deviceName>Antithrombin III (AT Ⅲ) Assay Kit (Chromogenic  Substrate Method)、Antithrombin Ⅲ (AT Ⅲ) Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-013241-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:37:58.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053025720</udiDi>
    <basicUdiDi>69449040AB75000045R</basicUdiDi>
    <tradeName>Activated Partial Thromboplastin Time (APTT) Assay Kit  (Clotting Method)</tradeName>
    <deviceName>Activated Partial Thromboplastin Time (APTT) Assay Kit  (Clotting Method)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029077-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:37:57.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041019468</udiDi>
    <basicUdiDi>B-62230041019468</basicUdiDi>
    <tradeName>D-Dimer Turbi Latex</tradeName>
    <deviceName>D-Dimer Turbi Latex</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>585 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T01:47:40.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784460303</udiDi>
    <basicUdiDi>B-06935784460303</basicUdiDi>
    <tradeName>06935784460303</tradeName>
    <deviceName>D-Dimer Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:45.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247281156</udiDi>
    <basicUdiDi>69382472IBS-13L8</basicUdiDi>
    <tradeName>06938247281156</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>876E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:57:07.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414792461</udiDi>
    <basicUdiDi>695441471339HV</basicUdiDi>
    <tradeName>D-Dimer Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>D-Dimer Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF5006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:48:35.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238302</udiDi>
    <basicUdiDi>0405686902152V9</basicUdiDi>
    <tradeName>Antiserum to Human Plasminogen</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_AS_Plasm</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020505</emdnCode>
    <emdnDescription>PLASMINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873656</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:17.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238296</udiDi>
    <basicUdiDi>0405686902149VL</basicUdiDi>
    <tradeName>Antiserum to Human Antithrombin III</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG _AS_ATIII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873655</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:13.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238289</udiDi>
    <basicUdiDi>0405686902151V7</basicUdiDi>
    <tradeName>Antiserum to Human Fibrinogen</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_AS_FIB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873654</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:12.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155011153</udiDi>
    <basicUdiDi>B-18430155011153</basicUdiDi>
    <tradeName>CALIBRADOR DE COAGULACIÓN</tradeName>
    <deviceName>CALIBRADOR DE COAGULACIÓN</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990945</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:19.736Z</lastUpdated>
  </row>
</eudamedExport>