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<eudamedExport entity="devices">
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    <basicUdiDi>B-06974703160184</basicUdiDi>
    <tradeName>qLabs® PT-INR Liquid Control</tradeName>
    <deviceName>qLabs® PT-INR Liquid Control</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-1-CL Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:42.786Z</lastUpdated>
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    <udiDi>06974703160177</udiDi>
    <basicUdiDi>B-06974703160177</basicUdiDi>
    <tradeName>qLabs® Coag Panel 2 Test Strips</tradeName>
    <deviceName>qLabs® Coag Panel 2 Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-4 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:41.980Z</lastUpdated>
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    <udiDi>06974703160160</udiDi>
    <basicUdiDi>B-06974703160160</basicUdiDi>
    <tradeName>qLabs® APTT Test Strips</tradeName>
    <deviceName>qLabs® APTT Test Strips</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020802</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-9 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:40.384Z</lastUpdated>
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    <udiDi>06974674891735</udiDi>
    <basicUdiDi>B-06974674891735</basicUdiDi>
    <tradeName>D-dimer Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>D-dimer Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</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>18-02-0120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:11.489Z</lastUpdated>
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    <udiDi>06974566303414</udiDi>
    <basicUdiDi>B-06974566303414</basicUdiDi>
    <tradeName>Filariasis IgG/IgM Rapid Test</tradeName>
    <deviceName>Filariasis IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</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>IFI-422</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:52.750Z</lastUpdated>
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    <udiDi>06952804825928</udiDi>
    <basicUdiDi>B-06952804825928</basicUdiDi>
    <tradeName>06952804825928</tradeName>
    <deviceName>D-Dimer Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G110A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:35.089Z</lastUpdated>
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    <udiDi>04260160470068</udiDi>
    <basicUdiDi>B-04260160470068</basicUdiDi>
    <tradeName>ap-tem</tradeName>
    <deviceName>ap-tem</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:24.789Z</lastUpdated>
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    <udiDi>03532670102823</udiDi>
    <basicUdiDi>B-03532670102823</basicUdiDi>
    <tradeName>Ksmart D-DIMER + Controls</tradeName>
    <deviceName>Ksmart D-DIMER + Controls</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1050003_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:12.255Z</lastUpdated>
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    <udiDi>03532670102700</udiDi>
    <basicUdiDi>B-03532670102700</basicUdiDi>
    <tradeName>Ksmart D-DIMER</tradeName>
    <deviceName>KSMART D-DIMER</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1050003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:06.656Z</lastUpdated>
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    <udiDi>D-02B0006YM</udiDi>
    <basicUdiDi>B-02B0006YM</basicUdiDi>
    <tradeName>D-02B0006YM</tradeName>
    <deviceName>Prothrombin Time Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1S001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:51.820Z</lastUpdated>
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    <udiDi>D-02B0007YP</udiDi>
    <basicUdiDi>B-02B0007YP</basicUdiDi>
    <tradeName>D-02B0007YP</tradeName>
    <deviceName>APTT/PT/TT/FIB Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020802</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:51.037Z</lastUpdated>
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  <row>
    <udiDi>06970581432078</udiDi>
    <basicUdiDi>B-06970581432078</basicUdiDi>
    <tradeName>Accu-Tell® D-Dimer Cassette (Whole Blood/Plasma/Serum)</tradeName>
    <deviceName>Accu-Tell® Rapid D-Dimer Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:41.523Z</lastUpdated>
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  <row>
    <udiDi>06952804802813</udiDi>
    <basicUdiDi>B-06952804802813</basicUdiDi>
    <tradeName>D-Dimer FIA</tradeName>
    <deviceName>D-Dimer FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDM-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:08.115Z</lastUpdated>
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  <row>
    <udiDi>06950334804536</udiDi>
    <basicUdiDi>B-06950334804536</basicUdiDi>
    <tradeName>D-Dimer test kit (Immunofluorescence)</tradeName>
    <deviceName>D-Dimer test kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52026017</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:40:29.237Z</lastUpdated>
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  <row>
    <udiDi>06937339209689</udiDi>
    <basicUdiDi>B-06937339209689</basicUdiDi>
    <tradeName>D-Dimer Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCDI-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:57.790Z</lastUpdated>
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    <udiDi>06438115001645</udiDi>
    <basicUdiDi>B-06438115001645</basicUdiDi>
    <tradeName>QuikRead CRP Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154812</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:08.995Z</lastUpdated>
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    <udiDi>06438115001560</udiDi>
    <basicUdiDi>B-06438115001560</basicUdiDi>
    <tradeName>QuikRead go HbA1c Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>154520</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:06.612Z</lastUpdated>
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    <udiDi>06438115001515</udiDi>
    <basicUdiDi>B-06438115001515</basicUdiDi>
    <tradeName>QuikRead go CRP Control Low</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153765</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:01.819Z</lastUpdated>
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    <udiDi>06438115001508</udiDi>
    <basicUdiDi>B-06438115001508</basicUdiDi>
    <tradeName>QuikRead go CRP Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153764</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:00.588Z</lastUpdated>
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    <udiDi>06438115000693</udiDi>
    <basicUdiDi>B-06438115000693</basicUdiDi>
    <tradeName>Urine Albumin Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67881</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:07:14.959Z</lastUpdated>
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