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    <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>105-023631-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:11.466Z</lastUpdated>
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    <udiDi>06925912736295</udiDi>
    <basicUdiDi>692591270288J3</basicUdiDi>
    <tradeName>iFlash-FDP</tradeName>
    <deviceName>iFlash-FDP</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>C86138-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:37:01.048Z</lastUpdated>
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    <udiDi>03607450012330</udiDi>
    <basicUdiDi>36074509FDP00047X</basicUdiDi>
    <tradeName>sthemO FDP</tradeName>
    <deviceName>sthemO FDP</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01233</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:10:53.309Z</lastUpdated>
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    <udiDi>03607450006490</udiDi>
    <basicUdiDi>36074509FDP00017R</basicUdiDi>
    <tradeName>STA® - Liatest® FDP</tradeName>
    <deviceName>STA® - Liatest® FDP</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00649</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:10:23.684Z</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>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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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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    <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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    <udiDi>03607450008876</udiDi>
    <basicUdiDi>B-03607450008876</basicUdiDi>
    <tradeName>F.S. Test Unit</tradeName>
    <deviceName>F.S. Test Unit</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00887</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:47:03.076Z</lastUpdated>
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    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103020502</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00857</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:47:01.814Z</lastUpdated>
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    <tradeName>FDP (eCLIA)</tradeName>
    <deviceName>FDP (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:38.250Z</lastUpdated>
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    <tradeName>D-EBL21070078J</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2107007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:24.106Z</lastUpdated>
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    <tradeName>D-EBL21060078B</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2106007</reference>
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    <lastUpdated>2026-07-13T15:22:19.306Z</lastUpdated>
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