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    <tradeName>TruHemo</tradeName>
    <deviceName>Coag Normal Control</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
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    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>B-15065026245103</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>Coag 4 Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
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    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
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    <tradeName>TruHemo</tradeName>
    <deviceName>Coag 2 Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-15065026245080</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>ACT Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020804</emdnCode>
    <emdnDescription>ACTIVATED CLOTTING TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:10.025Z</lastUpdated>
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    <udiDi>15065026245073</udiDi>
    <basicUdiDi>B-15065026245073</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>TT Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:09.234Z</lastUpdated>
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    <udiDi>15065026245066</udiDi>
    <basicUdiDi>B-15065026245066</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>FIB Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:08.429Z</lastUpdated>
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    <udiDi>15065026245059</udiDi>
    <basicUdiDi>B-15065026245059</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>APTT Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020802</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:04.539Z</lastUpdated>
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    <udiDi>15065026245042</udiDi>
    <basicUdiDi>B-15065026245042</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>PT/INR Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:02.825Z</lastUpdated>
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    <udiDi>15065023763457</udiDi>
    <basicUdiDi>B-15065023763457</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>D-Dimer Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:20.245Z</lastUpdated>
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    <udiDi>14562185400950</udiDi>
    <basicUdiDi>B-14562185400950</basicUdiDi>
    <tradeName>14562185400950</tradeName>
    <deviceName>CL AIA-PACK D-Dimer TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029142</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:50.474Z</lastUpdated>
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    <udiDi>14562185400967</udiDi>
    <basicUdiDi>B-14562185400967</basicUdiDi>
    <tradeName>14562185400967</tradeName>
    <deviceName>CL AIA-PACK D-Dimer ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029242</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:48.185Z</lastUpdated>
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    <tradeName>14560189213033</tradeName>
    <deviceName>ST AIA-PACK D-Dimer</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025232</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:19.543Z</lastUpdated>
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    <udiDi>14560189212777</udiDi>
    <basicUdiDi>B-14560189212777</basicUdiDi>
    <tradeName>14560189212777</tradeName>
    <deviceName>ST AIA-PACK Homocysteine</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025226</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:13.942Z</lastUpdated>
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    <udiDi>D-115H204TSCJW</udiDi>
    <basicUdiDi>B-115H204TSCJW</basicUdiDi>
    <tradeName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115H204TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:51:47.295Z</lastUpdated>
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    <udiDi>D-115H34TSC3U</udiDi>
    <basicUdiDi>B-115H34TSC3U</basicUdiDi>
    <tradeName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115H34TSC</reference>
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    <lastUpdated>2026-07-11T02:51:44.887Z</lastUpdated>
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    <tradeName>TRAP-6</tradeName>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>86926</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:22.303Z</lastUpdated>
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    <tradeName>Epinephrine</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-11T02:50:21.503Z</lastUpdated>
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    <tradeName>Collagen</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ADP</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:16.702Z</lastUpdated>
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    <tradeName>Arachidonic acid</tradeName>
    <deviceName>Arachidonic acid</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86922</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:15.899Z</lastUpdated>
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