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<eudamedExport entity="devices">
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    <udiDi>08431673792312</udiDi>
    <basicUdiDi>B-08431673792312</basicUdiDi>
    <tradeName>D-DIMER</tradeName>
    <deviceName>D-Dimer</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1709231</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:23.450Z</lastUpdated>
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    <udiDi>06971348762230</udiDi>
    <basicUdiDi>B-06971348762230</basicUdiDi>
    <tradeName>D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-34-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:12.443Z</lastUpdated>
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  <row>
    <udiDi>06971348760380</udiDi>
    <basicUdiDi>B-06971348760380</basicUdiDi>
    <tradeName>D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-34-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:46.026Z</lastUpdated>
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    <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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    <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>
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  <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>
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  <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>
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  <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>
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  <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-R076193B</udiDi>
    <basicUdiDi>B-R076193B</basicUdiDi>
    <tradeName>D-R076193B</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07619</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:37.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0761839</udiDi>
    <basicUdiDi>B-R0761839</basicUdiDi>
    <tradeName>D-R0761839</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07618</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:36.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0761533</udiDi>
    <basicUdiDi>B-R0761533</basicUdiDi>
    <tradeName>D-R0761533</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07615</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:33.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R076142Z</udiDi>
    <basicUdiDi>B-R076142Z</basicUdiDi>
    <tradeName>D-R076142Z</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:32.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R076132X</udiDi>
    <basicUdiDi>B-R076132X</basicUdiDi>
    <tradeName>D-R076132X</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:31.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R076122V</udiDi>
    <basicUdiDi>B-R076122V</basicUdiDi>
    <tradeName>D-R076122V</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07612</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:29.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R076112T</udiDi>
    <basicUdiDi>B-R076112T</basicUdiDi>
    <tradeName>D-R076112T</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R07611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:27.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R076112FB</udiDi>
    <basicUdiDi>B-R076112FB</basicUdiDi>
    <tradeName>D-R076112FB</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R076112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:26.390Z</lastUpdated>
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  <row>
    <udiDi>D-R076111F9</udiDi>
    <basicUdiDi>B-R076111F9</basicUdiDi>
    <tradeName>D-R076111F9</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R076111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:25.078Z</lastUpdated>
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    <udiDi>D-R076110F7</udiDi>
    <basicUdiDi>B-R076110F7</basicUdiDi>
    <tradeName>D-R076110F7</tradeName>
    <deviceName>Fibrin and Fibrinogen Degradation Products Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R076110</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:57:23.481Z</lastUpdated>
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  <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>
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</eudamedExport>