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    <basicUdiDi>912003686TC9C0000002ZP</basicUdiDi>
    <tradeName>09120036860599</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020901</emdnCode>
    <emdnDescription>CALCIUM CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5279027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.521Z</lastUpdated>
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    <udiDi>09120036860865</udiDi>
    <basicUdiDi>912003686TC9G000000144</basicUdiDi>
    <tradeName>09120036860865</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5400047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.471Z</lastUpdated>
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    <udiDi>09120036860889</udiDi>
    <basicUdiDi>912003686TC9J00000015V</basicUdiDi>
    <tradeName>09120036860889</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5410010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.424Z</lastUpdated>
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    <udiDi>09120036860896</udiDi>
    <basicUdiDi>912003686TC9J00000015V</basicUdiDi>
    <tradeName>09120036860896</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5410012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.392Z</lastUpdated>
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    <udiDi>09120036863675</udiDi>
    <basicUdiDi>912003686TC9J00000015V</basicUdiDi>
    <tradeName>09120036863675</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5410007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.141Z</lastUpdated>
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  <row>
    <udiDi>09120036863682</udiDi>
    <basicUdiDi>912003686TC9C0000001ZM</basicUdiDi>
    <tradeName>09120036863682</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020901</emdnCode>
    <emdnDescription>CALCIUM CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5277020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.117Z</lastUpdated>
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  <row>
    <udiDi>06903053025867</udiDi>
    <basicUdiDi>69449040AB75000015K</basicUdiDi>
    <tradeName>Fibrin(ogen) Degradation Products (FDP) Assay Kit  (lmmunoturbidimetry Method)</tradeName>
    <deviceName>Fibrin(ogen) Degradation Products (FDP) Assay Kit  (lmmunoturbidimetry Method)、Fibrin(ogen) Degradation Products (FDP) Calibrators、Fibrin(ogen) Degradation Products (FDP) 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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029092-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T12:59:32.965Z</lastUpdated>
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  <row>
    <udiDi>06903053025843</udiDi>
    <basicUdiDi>69449040AB75000055T</basicUdiDi>
    <tradeName>Prothrombin Time (PT) Assay Kit (Clotting Method)</tradeName>
    <deviceName>Prothrombin Time (PT) 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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029090-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T12:59:32.167Z</lastUpdated>
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  <row>
    <udiDi>06903053025829</udiDi>
    <basicUdiDi>69449040AB75000035P</basicUdiDi>
    <tradeName>Thrombin Time (TT) Assay Kit (Clotting Method)</tradeName>
    <deviceName>Thrombin Time (TT) 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029088-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T12:59:31.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053025744</udiDi>
    <basicUdiDi>69449040AB75000025M</basicUdiDi>
    <tradeName>D-Dimer Assay Kit (Immunoturbidimetry Method)</tradeName>
    <deviceName>D-Dimer Assay Kit (Immunoturbidimetry Method)、D-Dimer Calibrators、D-Dimer 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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029079-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T12:59:30.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120036862708</udiDi>
    <basicUdiDi>B-09120036862708</basicUdiDi>
    <tradeName>09120036862708</tradeName>
    <deviceName>TECHNOCLOT PT Plus</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003222</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:02.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120036862692</udiDi>
    <basicUdiDi>B-09120036862692</basicUdiDi>
    <tradeName>09120036862692</tradeName>
    <deviceName>TECHNOCLOT PT Plus</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003220</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:01.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1511425</udiDi>
    <basicUdiDi>B-R1511425</basicUdiDi>
    <tradeName>D-R1511425</tradeName>
    <deviceName>D-Dimer Reagent Kit (Chemiluminescent Immunoassay)</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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:41.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1511323</udiDi>
    <basicUdiDi>B-R1511323</basicUdiDi>
    <tradeName>D-R1511323</tradeName>
    <deviceName>D-Dimer Reagent Kit (Chemiluminescent Immunoassay)</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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:41.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R15112ZW</udiDi>
    <basicUdiDi>B-R15112ZW</basicUdiDi>
    <tradeName>D-R15112ZW</tradeName>
    <deviceName>D-Dimer Reagent Kit (Chemiluminescent Immunoassay)</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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:40.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R15111ZU</udiDi>
    <basicUdiDi>B-R15111ZU</basicUdiDi>
    <tradeName>D-R15111ZU</tradeName>
    <deviceName>D-Dimer Reagent Kit (Chemiluminescent Immunoassay)</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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:36.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R081122B</udiDi>
    <basicUdiDi>B-R081122B</basicUdiDi>
    <tradeName>D-R081122B</tradeName>
    <deviceName>Fibrinogen Assay Reagent Kit(Liquid)(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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R08112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:06.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0811129</udiDi>
    <basicUdiDi>B-R0811129</basicUdiDi>
    <tradeName>D-R0811129</tradeName>
    <deviceName>Fibrinogen Assay Reagent Kit(Liquid)(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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R08111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:05.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R081132D</udiDi>
    <basicUdiDi>B-R081132D</basicUdiDi>
    <tradeName>D-R081132D</tradeName>
    <deviceName>Fibrinogen Assay Reagent Kit(Liquid)(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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R08113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:05.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0801328</udiDi>
    <basicUdiDi>B-R0801328</basicUdiDi>
    <tradeName>D-R0801328</tradeName>
    <deviceName>Thrombin Time Assay Reagent Kit(Liquid) (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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R08013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:00.483Z</lastUpdated>
  </row>
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